FDA.reportPublic FDA data

Infinix Universal Bond - Primer

Primary DI
17290017528370
Brand
Infinix Universal Bond - Primer
Company
NOBIO LTD
Model
INF-PR-PP-MD2.5ML
Device description
Universal Bond- Primer 2.5ml for starter kit
Published
2021-03-18
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
true

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183391000Novidia Universal BondNobio , Ltd.2019-09-24KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017528370PackageGS11In Commercial Distribution
07290017528335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001752837017290017528370
07290017528335072900175283357290017528335

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532282466
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290017528073Infinix Universal CompositeINF-UC-FP-SD-A32021-03-15
17290017528080Infinix Universal CompositeINF-UC-FP-SD-B12021-03-15
07290017528335Infinix Universal Bond - PrimerINF-PR-PP-MD2.5ML2021-03-18
07290017528298Infinix Universal Bond- BondINF-BOND-PP-MD2.5ML2021-03-18
07290017528304Infinix Universal Bond - BondINF-BOND-PP-MD5ML2021-03-18
07290017528342Infinix Universal Bond - PrimerINF-PR-PP-MD5ML2021-03-18
17290017528059Infinix Universal CompositeINF-UC-FP-SD-A12021-03-15
17290017528066Infinix Universal CompositeINF-UC-FP-SD-A22021-03-15
17290017528097Infinix Universal CompositeINF-UC-FP-SD-TR2021-03-15
17290017528165Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-A12021-03-15
17290017528172Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-A22021-03-15
17290017528189Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-A32021-03-15
17290017528264Infinix Flowable CompositeINF-FL-FP-SD-A12021-03-15
17290017528271Infinix Flowable CompositeINF-FL-FP-SD-A22021-03-15
17290017528288Infinix Flowable CompositeINF-FL-FP-SD-A32021-03-15
17290017528431Infinix Bulk Fill Flow CompositeINF-BF-FP-SD-TR2021-03-15
07290017528007Infinix Universal CompositeINF-UC-PP-MD-A12021-03-15
07290017528014Infinix Universal CompositeINF-UC-PP-MD-A22021-03-15
07290017528038Infinix Universal CompositeINF-UC-PP-MD-B12021-03-15
07290017528045Infinix Universal CompositeINF-UC-PP-MD-TR2021-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208302684SyntacIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-03-29
10371347008729Advance Dental ProductsThe Atlanta Dental Supply CompanyKLE2022-12-29