FDA.reportPublic FDA data

DENTECH

Primary DI
04560218661524
Brand
DENTECH
Company
DENTECH CORPORATION
Model
01022020
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJEFrame, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJEFrame, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560218661524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560218661524045602186615244560218661524

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam frameA flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
700723000
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560218663887DENTECH030500002020-09-24
04560218681928DENTECH300604302020-09-24
04560218681935DENTECH300605002020-09-24
04560218681942DENTECH300602402020-09-24
04560218681959DENTECH300602702020-09-24
04560218681966DENTECH300603002020-09-24
04560218681973DENTECH300603302020-09-24
04560218681980DENTECH300603802020-09-24
04560218681997DENTECH300606002020-09-24
04560218682109DENTECH300706002020-09-24
04560218682116DENTECH300708002020-09-24
04560218682123DENTECH300710002020-09-24
04560218682154DENTECH300705002020-09-24
04560218682161DENTECH300712002020-09-24
04560218676818DENTECH300147422024-01-17
04560218669773DENTECH010149992022-08-26
04560218660718DENTECH500300002021-09-30
04560218660442DENTECH010182122020-09-24
04560218660589DENTECH507106002020-09-24
04560218660596DENTECH507107002020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB2100TBS BASICSACME ENTERPRISE.EJE2026-05-16
00813677023339PDT, Inc.PDT, INC.EJE2024-06-27
00813677024985PDT, Inc.PDT, INC.EJE2024-06-27
D2483553190Plast FrameHAGER WORLDWIDE, INC.EJE2024-04-16
08800075603463OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
08800075603470OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
07506338321761Nic Tone, MDC Dental MDC DENTALEJE2023-11-17
00014081053190Plast FrameHAGER WORLDWIDE, INC.EJE2023-03-27
07630392900409HysolateDent4You AGEJE2023-02-28
07630392900416HysolateDent4You AGEJE2023-02-28
07630392900423HysolateDent4You AGEJE2023-02-28
07630392900430HysolateDent4You AGEJE2023-02-28
07630392900447HysolateDent4You AGEJE2023-02-28
07506338300575Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300667Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300674Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300681Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300698Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300704Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300568Nic Tone, MDC DentalMDC DENTALEJE2022-12-08
07506338300599Nic Tone, MDC Dental MDC DENTALEJE2022-12-08
D24835531919Plast FrameHAGER WORLDWIDE, INC.EJE2022-12-05
07506338300582Nic Tone, MDC DentalMDC DENTALEJE2022-11-04
07506338300636Nic Tone, MDC Dental MDC DENTALEJE2022-11-03
00302731714011YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731770017YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731771014YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731776019YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731777016YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731714018YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16