• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device material, tooth shade, resin
Regulation Description Tooth shade resin material.
Product CodeEBF
Regulation Number 872.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIODEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOLOREN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BREDENT GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
CENDRES+METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 4
COSMEDENT, INC
  SUBSTANTIALLY EQUIVALENT 3
DEN-MAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 4
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
DMG USA INC.
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
FIGARO CROWNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 4
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 1
GREENWAY YW LLC
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC (MITSUI CHEMICALS GROUP)
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
MERZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
SCHUETZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCHUTZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
SWISSMEDITEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
ULTRADENT PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 9
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 143 143
2017 42 42
2018 8 8
2019 11 11
2020 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 175 175
Adverse Event Without Identified Device or Use Problem 14 14
Patient-Device Incompatibility 11 11
Fracture 2 2
Melted 2 2
Migration or Expulsion of Device 2 2
Nonstandard Device 2 2
Fire 2 2
Smoking 2 2
Expiration Date Error 1 1
Fluid Leak 1 1
Device Emits Odor 1 1
Off-Label Use 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 176 176
Hypersensitivity/Allergic reaction 9 9
Pain 8 8
Complaint, Ill-Defined 4 4
Rash 4 4
Swelling 4 4
No Information 3 3
Burning Sensation 3 3
Discomfort 2 2
Hair Loss 2 2
Patient Problem/Medical Problem 2 2
Tooth Fracture 2 2
Sensitivity of Teeth 2 2
Irregular Pulse 1 1
Malaise 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Abscess 1 1
Erythema 1 1
Intraoperative Pain 1 1
Tissue Breakdown 1 1
Arthralgia 1 1
Joint Swelling 1 1
Reaction 1 1
Unspecified Infection 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Local Reaction 1 1
Thyroid Problems 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar Vivadent, Inc. III Feb-21-2018
2 RHONDIUM LIMITED II Dec-19-2019
3 Ultradent Products, Inc. II Oct-02-2020
4 Voco Chemie Gmbh II Oct-01-2019
-
-