FDA.reportPublic FDA data

POLIGLOSS

Primary DI
07897990330421
Brand
POLIGLOSS
Company
TDV DENTAL LTDA
Model
0001050000
Catalog number
0001050000
Device description
Poligloss - 3g
Published
2025-02-28
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
true

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990330421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990330421078979903304217897990330421

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900580358
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
07897990399091UNIMATRIX S000302030100030203012026-02-18
07897990399213UNIMATRIX S000302030000030203002026-02-18
07897990399220UNIMATRIX S000302030200030203022026-02-18
07897990301919METALLIC MATRIX STRIP000306000700030600072025-03-04
07897990301940METALLIC MATRIX STRIP000306001000030600102025-03-04
07897990302244ANATOMIC WEDGES000402002200040200222025-03-04
07897990302251ANATOMIC WEDGES000402002300040200232025-03-04
07897990302268ANATOMIC WEDGES000402002400040200242025-03-04
07897990302343MICROCUT MANUAL000500000700050000072025-03-04
07897990302428TRANSPARENT CROWNS000800000500080000052025-03-04
07897990302435TRANSPARENT CROWNS000800000600080000062025-03-04
07897990302442TRANSPARENT CROWNS000800000700080000072025-03-04
07897990302466TRANSPARENT CROWNS000800000900080000092025-03-04
07897990306297METALLIC MATRIX STRIP000306001800030600182025-03-04
07897990306303METALLIC MATRIX STRIP000306001900030600192025-03-04
07897990307126TRANSPARENT CROWNS000800050000080005002025-03-04
07897990307133TRANSPARENT CROWNS000800050100080005012025-03-04
07897990307140TRANSPARENT CROWNS000800050200080005022025-03-04
07897990307157TRANSPARENT CROWNS000800050300080005032025-03-04
07897990307164TRANSPARENT CROWNS000800050400080005042025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810184450009RodinPac-Dent, Inc.EJR2026-03-23
00810184450016RodinPac-Dent, Inc.EJR2026-03-23
00810184450023RodinPac-Dent, Inc.EJR2026-03-23
E241BW9100Cavex Prophy Paste RegularCavex Holland B.V.EJR2026-03-11
E241BW9110Cavex Prophy Paste FineCavex Holland B.V.EJR2026-03-11
00883205042835OpalustreULTRADENT PRODUCTS, INC.EJR2026-03-10
10190707191174Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310231029993ProphyCare HApDirecta ABEJR2025-09-01
00348783012989Enamel Pro® Prophy PastePREMIER DENTAL PRODUCTS COMPANYEJR2025-07-16
00304040192771Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
06971560453466REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453473REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453480REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453497REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
06971560453503REFINEGuilin Refine Medical Instrument Co.,LTD.EJR2025-06-30
D0337884100Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D0337884110Kolorz Prophylaxis PasteDMG AMERICA, LLCEJR2025-06-04
D950116471PastelLARES RESEARCHEJR2025-05-02
D950116481PastelLARES RESEARCHEJR2025-05-02
00359883003081Contours™ Coarse Anatomy Trimmers Shape 05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003098Contours™ Coarse Anatomy Trimmers Shape 06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003104Contours™ Coarse Anatomy Trimmers Shape 08DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003111Contours™ Course Anatomy Trimers Starter KitDEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003500D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003517D-Fine™ Diamond Polishers for Hybrid Composites Pre-Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003524D-Fine™ Diamond Polishers for Hybrid Composites Diamond Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003609D-Fine Double Diamond™ Primary Polisher Refill #04DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003616D-Fine Double Diamond™ Primary Polisher Refill #05DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003623D-Fine Double Diamond™ Primary Polisher Refill #06DEN-MAT HOLDINGS, LLCEJR2025-03-12
00359883003630D-Fine Double Diamond™ Primary Polisher Refill #08DEN-MAT HOLDINGS, LLCEJR2025-03-12