DENTECH

Primary DI
04560218661470
Brand
DENTECH
Company
DENTECH CORPORATION
Model
01030130
Device description
Rubber Dam Starter Kit, Glossy. This set includes non-latex dental dam. So, we put "Yes" for Expiration Date. "For Single use", we put "No" by considering Rubber Dam Clamp and other stainless items in this set. But non-latex dental dam(included in this set) is for single use.
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560218661470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560218661470045602186614704560218661470

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam kitA collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. 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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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