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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 ESPE DENTAL PRODUCTS
  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
CENDRES+METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
COLTENE/WHALEDENT AG
  SUBSTANTIALLY EQUIVALENT 3
COSMEDENT, INC
  SUBSTANTIALLY EQUIVALENT 3
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
DEN-MAT HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTKIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 5
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
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 2
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 1
GREENWAY YW LLC
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERFECT FIT CROWNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
SAREMCO DENTAL AG
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SWISSMEDITEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
ULTRADENT PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 7
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 42 42
2018 8 8
2019 11 11
2020 2 2
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 42 42
Adverse Event Without Identified Device or Use Problem 13 13
Patient-Device Incompatibility 11 11
Device Operates Differently Than Expected 1 1
Fluid Leak 1 1
Off-Label Use 1 1
Improper or Incorrect Procedure or Method 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 41 41
Hypersensitivity/Allergic reaction 9 9
Pain 8 8
Rash 5 5
Sensitivity of Teeth 4 4
Swelling 3 3
Burning Sensation 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Hair Loss 2 2
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Blister 1 1
Arthralgia 1 1
Joint Swelling 1 1
Malaise 1 1
Tooth Fracture 1 1
Irregular Pulse 1 1
Intraoperative Pain 1 1
Tissue Breakdown 1 1
No Information 1 1
Thyroid Problems 1 1
Abscess 1 1
Autoimmune Disorder 1 1
Chest Pain 1 1
Dyspnea 1 1
Erythema 1 1
Fatigue 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
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