FDA.reportPublic FDA data

DENTECH

Primary DI
04560218661197
Brand
DENTECH
Company
DENTECH CORPORATION
Model
01021011
Published
2020-09-24
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

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
04560218661197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560218661197045602186611974560218661197

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam punchA hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
700723000
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560218676818DENTECH300147422024-01-17
04560218669773DENTECH010149992022-08-26
04560218660718DENTECH500300002021-09-30
04560218660442DENTECH010182122020-09-24
04560218660589DENTECH507106002020-09-24
04560218660596DENTECH507107002020-09-24
04560218667120DENTECH061221002020-09-24
04560218667243DENTECH063010102020-09-24
04560218667489DENTECH070001002020-09-24
04560218667496DENTECH070001012020-09-24
04560218667502DENTECH070001022020-09-24
04560218667519DENTECH070001032020-09-24
04560218667533DENTECH070001052020-09-24
04560218667540DENTECH070001062020-09-24
04560218668493DENTECH070001502020-09-24
04560218669377DENTECH010182132020-09-24
04560218669452DENTECH010149022020-09-24
04560218669469DENTECH010149032020-09-24
04560218669476DENTECH010149072020-09-24
04560218669483DENTECH010149082020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800019151067BL Clamp B& L Biotech, inc.EJG2025-07-18
07899798207721QuinelatoSchobell Industrial LtdaEJG2025-02-27
00889813063583Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEJG2024-11-30
00348783001488Premier Rubber Dam PunchPREMIER DENTAL PRODUCTS COMPANYEJG2024-08-01
00813677023315PDT, Inc.PDT, INC.EJG2024-06-27
00813677023322PDT, Inc.PDT, INC.EJG2024-06-27
00348783010602Premier Rubber Dam ClampPREMIER DENTAL PRODUCTS COMPANYEJG2024-04-10
D9495000821Bioclear InstrumentBioclear Matrix SystemsEJG2024-04-05
08800075603449OSUNG MNDOSUNG MND Co., Ltd.EJG2024-02-23
08964003163532NivoB. Ali ImpexEJG2024-01-29
08964003163600Doctor NiceB. Ali ImpexEJG2024-01-29
08964003163273NivoB. Ali ImpexEJG2024-01-27
D9495000813Bioclear InstrumentBioclear Matrix SystemsEJG2023-09-11
D9495000811Bioclear InstrumentBioclear Matrix SystemsEJG2023-08-10
05055382843894DentalTIMESCO HEALTHCARE LIMITEDEJG2023-07-06
00840105222866ZOLL DENTALZoll-DentalEJG2023-04-20
07630392900393HysolateDent4You AGEJG2023-02-28
EZPF19010000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19037010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19125000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
07898506811823QuinelatoSchobell Industrial LtdaEJG2022-10-24
00810060722541Rubber dam forceps Berman Instruments LLCEJG2022-09-21
00810038090429Composi-Tight®GARRISON DENTAL SOLUTIONS, L.L.C.EJG2022-08-31