FDA.reportPublic FDA data

NEW METAL STRIPS

Primary DI
14548161391672
Brand
NEW METAL STRIPS
Company
Gc America Inc.
Model
000257
Catalog number
000257
Device description
NEW METAL STRIPS, Refill Package, #300 Mesh B-Width Blue
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHMSTRIP, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14548161391672PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1454816139167214548161391672

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
D6581200012COE ALGINATE™1200011200012016-08-01
D6581200051COE ALGINATE™1200051200052016-08-01
D6581200251COE ALGINATE™1200251200252016-08-01
D6581201012COE ALGINATE™1201011201012016-08-01
D6581210012COE ALGINATE™1210011210012016-08-01
D6581211012COE ALGINATE™1211011211012016-08-01
D6581240012COE HYDROPHILIC GEL™1240011240012016-08-01
D6581241012COE HYDROPHILIC GEL™1241011241012016-08-01
D6581241251COE HYDROPHILIC GEL™1241251241252016-08-01
D6581310022COE-FLEX®1310021310022016-08-01
D6581310032COE-FLEX®1310031310032016-08-01
D6581310042COE-FLEX®1310041310042016-08-01
D6581310052COE-FLEX®1310051310052016-08-01
D6581311022COE-FLEX®1311021311022016-08-01
D6581311032COE-FLEX®1311031311032016-08-01
D6581311042COE-FLEX®1311041311042016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07908738730561DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730578DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730301DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730318DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730325DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730332DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730356DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730363DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730370DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730387DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730394DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730400DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730417DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730424DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730431DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730448DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730455DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730462DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
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