FDA.reportPublic FDA data

Suppra O-Cem Plus

Primary DI
07899633828463
Brand
Suppra O-Cem Plus
Company
Dentscare Ltda
Model
4g
Catalog number
4000055571
Device description
Suppra O-Cem Plus is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product removal from teeth, after removing brackets.
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899633828463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899633828463078996338284637899633828463

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
898067533
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899633835249 PrimmaArtA1 7G40000566302025-04-08
07899633835256 PrimmaArtA2 7G 40000566312025-04-08
07899633835263 PrimmaArtA3 7G 40000566322025-04-08
07899633835270 PrimmaArtB1 7G 40000566332025-04-08
07899633835287 PrimmaArtBLEACH 7G 40000566342025-04-08
07899633835294 PrimmaArtA1 75G 40000566352025-04-08
07899633835300 PrimmaArtA2 75G 40000566362025-04-08
07899633835317 PrimmaArtA3 75G 4000056637 2025-04-08
07899633835324 PrimmaArtB1 75G 4000056638 2025-04-08
07899633835331 PrimmaArtBLEACH 75G 40000566392025-04-08
07899633835461 PrimmaArtCART 75G 20UN 40000566482025-04-08
07899633835478 PrimmaArtCART 75G 5UN 40000566492025-04-08
07899633835485 PrimmaArtREFIL 7G 20UN 40000566502025-04-08
07899633835492 PrimmaArtREFIL 7G 5UN 40000566512025-04-08
07899633835232Vittra APS Unique Flow2g40000566272024-11-26
07899633830886Suppra Universal Bond5mL40000559152023-06-01
07899633830893All Smiles Safebond5mL40000559112023-06-01
07899633828364Suppra Bond A Plus6mL40000554802021-10-01
07899633816552Allcem Veneer APSMini Kit40000192972020-09-14
07899633815913Ambar APS6mL40000193582020-01-31

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00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
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00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBF2026-10-08
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08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
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08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07