FDA.reportPublic FDA data

DENTAMERICA

Primary DI
00858466005073
Brand
DENTAMERICA
Company
DENTAMERICA, INC.
Model
403
Device description
SNAP-ON PROPHYLAXIS POLISHING CUPS
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHKCup, Prophylaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858466005073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858466005073008584660050738584660050730858466005073

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Regulatory Flags#

DUNS number
174436360
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850461008059APIXIA DIGIREX108LUSEXL2026-07-23
00850461008066APIXIA DIGIREX108MUSEXM2026-07-23
00850461008196APIXIA108102026-04-22
00850461008202APIXIA108112026-04-22
00850461008219APIXIA108122026-04-22
00850461008226APIXIA108132026-04-22
00850461008233APIXIA108142026-04-22
00850461008240APIXIA108552026-04-22
00858466005219SCALEX980P2026-04-22
00858466005257ENDOMAX178BRT2026-04-22
00850461008042APIXIA DIGIREX108US2026-04-21
00850461008097DIGIREX105MX2026-04-21
00858466005004POLYBITE8852026-04-21
00858466005011POLYBITE8862026-04-21
00858466005028POLYBITE8872026-04-21
00858466005035POLYBITE8882026-04-21
00858466005042POLYBITE8892026-04-21
00858466005059DENTAMERICA4012026-04-21
00858466005066DENTAMERICA4022026-04-21
00858466005080DENTAMERICA4152026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456220474JMUJMU DENTAL, INCEHK2026-07-07
00840456220481JMUJMU DENTAL, INCEHK2026-07-07
00840456220498JMUJMU DENTAL, INCEHK2026-07-07
00840456220504JMUJMU DENTAL, INCEHK2026-07-07
00840456220115JMUJMU DENTAL, INCEHK2026-06-25
00840456220122JMUJMU DENTAL, INCEHK2026-06-25
00840456220139JMUJMU DENTAL, INCEHK2026-06-25
00840456220146JMUJMU DENTAL, INCEHK2026-06-25
00840456220153JMUJMU DENTAL, INCEHK2026-06-25
00840456220160JMUJMU DENTAL, INCEHK2026-06-25
00840456220177JMUJMU DENTAL, INCEHK2026-06-25
00840456220184JMUJMU DENTAL, INCEHK2026-06-25
00840456220191JMUJMU DENTAL, INCEHK2026-06-25
00840456220207JMUJMU DENTAL, INCEHK2026-06-25
00840456220214JMUJMU DENTAL, INCEHK2026-06-25
00840456220221JMUJMU DENTAL, INCEHK2026-06-25
00840456220238JMUJMU DENTAL, INCEHK2026-06-25
00840456220245JMUJMU DENTAL, INCEHK2026-06-25
00840456220252JMUJMU DENTAL, INCEHK2026-06-25
00840456220269JMUJMU DENTAL, INCEHK2026-06-25
00840456220276JMUJMU DENTAL, INCEHK2026-06-25
07897990300103PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300110PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300127PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300219PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300233PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300264PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300271PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300288PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300295PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18