FDA.report

Wedges

Primary DI
D701WY2
Brand
Wedges
Company
PULPDENT CORPORATION
Model
W-Y
Device description
REFILL – bag of 100, Yellow=15mm
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JEPRetainer, Matrix

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701WY2PrimaryHIBCC0
D701WY1Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental wedge, single-useA dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D710VKBF1US2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1US2024-12-02
D701SUNO2DENTASTIC UNO SAMPLESUNO2018-08-10
D701SVPFA32Activa PrestoS-VPFA32023-06-22
D701SVPFA352Activa PrestoS-VPFA352023-06-22
D701SVPFA42Activa PrestoS-VPFA42023-06-22
D701SVPFA62Activa PrestoS-VPFA62023-06-22
D701SVPFB12Activa PrestoS-VPFB12023-06-22
D701TTP502Tuff Temp Plus Provisional Veneer, Crown, and Bridge ResinTTP502018-12-14
D701TTP50A12TUFF-TEMP PLUSTTP50A12019-11-22
D701TTP50A1X2TUFF-TEMP PLUSTTP50A1X2019-11-22
D701TTP50A22TUFF-TEMP PLUSTTP50A22019-11-22
D701TTP50A2X2TUFF-TEMP PLUSTTP50A2X2019-11-22
D701TTP50A32TUFF-TEMP PLUSTTP50A32019-11-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
008101265081643D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081883D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081953D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
00840456215227Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456215234Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
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10840326423889AstekYoung Innovations, Inc.JEP2025-03-17
00810038091129Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
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