Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Product CodeEBF
Regulation Number 872.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
3M COMPANY ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
AB ARDENT
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANAXDENT GMBH
  SUBSTANTIALLY EQUIVALENT 1
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS
  SUBSTANTIALLY EQUIVALENT 1
APEX DENTAL MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BICON, LLC
  SUBSTANTIALLY EQUIVALENT 2
BIODEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOLOREN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BIOLOREN SRL
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 2
BREDENT GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
CENDRES+METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 6
COSMEDENT, INC
  SUBSTANTIALLY EQUIVALENT 4
COSMEDENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KG
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS INC.
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS LLC
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DANVILLE MATERIALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
DEN-MAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 2
DENALI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 5
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2
DETAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
DISCUS DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DMG USA INC.
  SUBSTANTIALLY EQUIVALENT 1
DMG USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMP LTD
  SUBSTANTIALLY EQUIVALENT 3
DWS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
FIGARO CROWNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K151541  G-Fix
  2.  K153127  everX Posterior
  3.  K153325  Gradia Plus
  4.  K173500  NMF004A
  5.  K192260  everX Flow
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 5
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHENANO DENTAL S.L.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 2
GREENWAY YW LLC
  SUBSTANTIALLY EQUIVALENT 1
HDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS KULZER, LLC (MITSUI CHEMICALS GROUP)
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
  SUBSTANTIALLY EQUIVALENT 1
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 6
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 4
JUNO DENTISTRY LP
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
KETTENBACH GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
KM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 2
KURARAY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 4
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
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBIO LTD.
  SUBSTANTIALLY EQUIVALENT 4
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
  SUBSTANTIALLY EQUIVALENT 1
NOVOCOL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PAC-DENT INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PASCAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
PENTRON CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PENTRON CLINICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PERFECT FIT CROWNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL PRODUCTS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
RELIANCE ORTHODONTIC PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
RHONDIUM, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 3
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITATEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SAREMCO DENTAL AG
  SUBSTANTIALLY EQUIVALENT 2
SCHUETZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCHUTZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 3
SHOFU DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
SILMET LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SPRINTRAY INC.
  SUBSTANTIALLY EQUIVALENT 1
SWISSMEDITEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
ULTRADENT PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 24
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jul-08-2015
2 Ivoclar Vivadent, Inc. III Feb-21-2018
3 Kerr Corporation II Feb-28-2012
4 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Sep-19-2013
5 Kerr/pentron Dba Kerr Corporation And Pentron Clinical III Nov-03-2011
6 Patterson Dental Supply, Inc. II Dec-17-2010
7 RHONDIUM LIMITED II Dec-19-2019
8 Sybron Dental Specialties II Feb-13-2012
9 Sybron Dental Specialties II Feb-11-2012
10 Sybron Dental Specialties III Mar-02-2010
11 Ultradent Products, Inc. II Oct-02-2020
12 Voco GmbH II Oct-01-2019
-
-