FDA.reportPublic FDA data

Bioclear Instrument

Primary DI
D9495000821
Brand
Bioclear Instrument
Company
Bioclear Matrix Systems
Model
TwinRing Forceps
Device description
Metal instrument used in dental restorations.
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJGForceps, Rubber Dam Clamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9495000821PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
059020838
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9498010162Black Triangle (BT) KitStudent/EM2024-12-03
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
D9498271312Select Bioclear Evolve Posterior KitSelect2024-04-05
D9498271412Bioclear Evolve Posterior KitSelect Add-On Kit2024-04-05
D949112011021Bioclear Diamond WedgeSmall2023-09-16
D949112011041Bioclear Diamond WedgeSmall2023-09-16
D949112011081Bioclear Diamond WedgeSmall2023-09-16
D949112011101Bioclear Diamond WedgeSmall2023-09-16
D949112011161Bioclear Diamond WedgeSmall2023-09-16
D949112011500BG1Bioclear Diamond WedgeSmall2023-09-16
D949112011503Bioclear Diamond WedgeSmall2023-09-11
D94911201150BG1Bioclear Diamond WedgeSmall2023-09-16
D949112021021Bioclear Diamond WedgeMedium2023-09-16
D949112021041Bioclear Diamond WedgeMedium2023-09-16
D949112021081Bioclear Diamond WedgeMedium2023-09-16
D949112021101Bioclear Diamond WedgeMedium2023-09-16
D949112021161Bioclear Diamond WedgeMedium2023-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791032710DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032720DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G8791032760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
G149TBSB2110TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2120TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2130TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2150TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2160TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2170TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2180TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2190TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2200TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2210TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2220TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2230TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2240TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2250TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2260TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2270TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2280TBS BASICSACME ENTERPRISE.EJG2026-05-16
00371347023534Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
00371347023541Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
00371347023558Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
08800019151012BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151029BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151036BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151043BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151050BL Clamp B& L Biotech, inc.EJG2025-07-18