FDA.reportPublic FDA data

Hygenic

Primary DI
D661H012620
Brand
Hygenic
Company
COLTENE/WHALEDENT INC
Model
H01262
Device description
Clamp Forceps
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
D661H012620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clamp forcepsA hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.

Regulatory Flags#

DUNS number
622185718
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D661R100699C1AlpenR100699C2026-06-05
D661XL848SC0161AlpenXL848SC0162019-02-12
D661R862C016FG1AlpenR862C016FG2019-02-11
D661R862EF010FG1AlpenR862EF010FG2019-02-11
D661R862EF012FG1AlpenR862EF012FG2019-02-11
D661R862F010FG1AlpenR862F010FG2019-02-11
D661R862F012FG1AlpenR862F012FG2019-02-11
D661R862F016FG1AlpenR862F016FG2019-02-11
D661R862SC014FG1AlpenR862SC014FG2019-02-11
D661R862UF010FG1AlpenR862UF010FG2019-02-11
D661R862UF012FG1AlpenR862UF012FG2019-02-12
D661R863C012FG1AlpenR863C012FG2019-02-12
D661R863EF012B1AlpenR863EF012B2019-02-11
D661R863EF012FG1AlpenR863EF012FG2019-02-12
D661R863EF016FG1AlpenR863EF016FG2019-02-12
D661R863F012FG1AlpenR863F012FG2019-02-11
D661R863F016FG1AlpenR863F016FG2019-02-11
D661R863SC016FG1AlpenR863SC016FG2019-02-11
D661R864F014FG1AlpenR864F014FG2019-02-11
D661R877C010FG1AlpenR877C010FG2019-02-12

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