|
Device |
implant, endosseous, root-form |
Regulation Description |
Endosseous dental implant. |
Product Code | DZE |
Regulation Number |
872.3640
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABRACADABRA IMPLANTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADIN DENTAL IMPLANT SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADIN DENTAL IMPLANTS SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHA DENT IMPLANTS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALTATEC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANTHOGYR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARUM DENTISTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ARUMDENTISTRY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
B.T.I. BIOTECHNOLOGY INSTITUTE, SL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEGO IMPLANT SYSTEMS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO CONCEPT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOHORIZONS IMPLANT SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOHORIZONS IMPLANT SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET 3I LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET 3I, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTECH DENTAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTECH DENTAL, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BLUE SKY BIO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COWELLMEDI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CYBERMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
D.S.P INDUSTRIAL EIRELI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENQ |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTAL EVOLUTIONS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTIS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
DENTIUM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DENTSPLY SIRONA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DITRON DENTAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DSI DENTAL SOLUTIONS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBI INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
F&B TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FAICO MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUILIN FITEETH MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANGZHOU MINSHENG LIDE MEDICAL SCIENCE & TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIGHNESS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HIOSSEN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HOOWON EDI CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I DO BIOTECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IDIS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLANTS DIFFUSION INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INFINITUM ETA LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOBIOSURG CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
INSTITUT STRAUMANN AG |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
IVORY SUPER HOLDCO INC. / ZEST ANCHORS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IZENIMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
J DENTAL CARE S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JDENTALCARE SRL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGYIN JINTECH BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JJ MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KEYSTONE DENTAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
KJ MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDENTIKA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDENTIS MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL INSTINCT DEUTSCHLAND GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIMECCA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEGAGEN IMPLANT CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEGAGEN IMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MOZO GRAU S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOBIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEWTON IMPLANT SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEWTON IMPLANT SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBEL BIOCARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBEL BIOCARE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBEL BIOCARE SERVICES AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORIS MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORIS MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVODENT SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ONEDAY BIOTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSTEM IMPLANT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSVIS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSTEOCENTRIC TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PALTOP ADVANCED DENTAL SOLUTIONS, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
POINTNIX CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QRS MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUADRIC BIOMED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUICKDENT DEVICES PRIVATE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RDJ TOV IMPLANT LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
S.I.N. -SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.I.N.- SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.I.N.-SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANLILAR TIBBI CIHAZLAR MEDIKAL KIMYA SANAYI TICARET LTD. ST |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SDS SWISS DENTAL SOLUTIONS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEWON MEDIX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINHUNG MST CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIC INVENT AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SNUCONE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SOUTHERN IMPLANTS (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRAUMANN USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNCOAST DENTAL, INC. DBA TATUM SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURCAM MEDICAL DEVICES AND DEVELOPMENTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGIKOR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
T-PLUS IMPLANT TECH. CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERRATS MEDICAL SL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRATE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRI DENTAL IMPLANTS INT. AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRUABUTMENT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNIDENTAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
Z-SYSTEMS AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
Z7 LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZENTEK MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZEROS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2020 |
255524 |
246727 |
2021 |
479618 |
449271 |
2022 |
483224 |
593161 |
2023 |
537594 |
537685 |
2024 |
473635 |
697105 |
2025 |
46900 |
65489 |
|
|
|
|