FDA.report

TruContact

Primary DI
D9496130310
Brand
TruContact
Company
Bioclear Matrix Systems
Model
Blue
Device description
Strip with a handle that is used to break and lighten a contact between teeth to ease placement of matrix for dental restoration.
Published
2023-08-10
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
false

Related Records

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D94961303181PrimaryHIBCC0
D9496130310Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental abrasive strip, reusableA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
059020838
Device count
8
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
true

Other Devices From This Company

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D9498271712Evolve All-in-One Select KitFull2024-12-03
D9498271612Evolve All-in-One Select KitStudent/EM2024-10-22
D9499000412BT, Evolve, & DWSamples for 3M Heaters2024-08-20
D9498270912Evolve Matrix Procedure KitBrazil2024-07-10
D9495000821Bioclear InstrumentTwinRing Forceps2024-04-05
D9498271312Select Bioclear Evolve Posterior KitSelect2024-04-05
D9498271412Bioclear Evolve Posterior KitSelect Add-On Kit2024-04-05
D949208011R1Bioclear TwinRingMolar2023-09-16
D949208021R1Bioclear TwinRingPremolar2023-09-16
D9492080311Bioclear TwinRing Molar/Premolar PackMolar/Premolar Pack2023-09-16
D949208031K1Bioclear TwinRing Molar/Premolar PackMolar/Premolar Pack2023-09-16
D949303011B0Original Posterior Matrix B SeriesB301 Blue2023-09-11
D949303011C0Original Posterior Matrix B SeriesB301 Clear2023-09-11
D949303021B0Original Posterior Matrix B SeriesB302 Blue2023-09-11
D949303021C0Original Posterior Matrix B SeriesB302 Clear2023-09-11
D949303031B0Original Posterior Matrix B SeriesB303 Blue2023-09-11
D949303031C0Original Posterior Matrix B SeriesB303 Clear2023-09-11
D949304011B0Original Posterior Matrix M SeriesM401 Blue2023-09-11
D949304011C0Original Posterior Matrix M SeriesM401 Clear2023-09-11

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D690W801016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W801023M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W801L016C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W801L021M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
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D690W802016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014C0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805014M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W805016M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W811031M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830008M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16
D690W830010M0G2 DIAMONDSs White Burs, Inc.DZP2026-02-16