|
Device |
sterilization wrap containers, trays, cassettes & other accessories |
Product Code | KCT |
Regulation Number |
880.6850
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AESCULAP INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AESCULAP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANTHOGYR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AVALIGN TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVINENT IMPLANT SYSTEM S.L.U. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVINENT IMPLANT SYSTEM, S.L.U. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AYGUN SURGICAL INSTRUMENTS CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAHADIR USA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEGO IMPLANT SYSTEMS GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTECH DENTAL, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CALDERA MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CASE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COCHLEAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COCHLEAR AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DENTSPLY SIRONA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLOGIC, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLANT DIRECT SYBRON MANUFACTURING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INSTITUT STRAUMANN AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTUITIVE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
K1 MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
KARL STORZ ENDOSCOPY AMERICA INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KARL STORZ ENDOSCOPYAMERICA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOTRACT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NOBEL BIOCARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOBEL BIOCARE SERVICES AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
O&M HALYARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS WINTER & IBE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEOMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PMBS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RP MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
S.I.N. – SISTEMA DE IMPLANTE NACIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOUTHERN IMPLANTS (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERICUBE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STRAUMANN USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUMMITT MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SWEDEN & MARTINA S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES (USA) PRODUCTS LLC / DEPUY ORTHOPAEDICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THINK SURGICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THINK SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
Z-SYSTEMS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|