FDA.reportPublic FDA data

OSE

Primary DI
00869843000277
Brand
OSE
Company
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Model
0167-000
Device description
POSI-Lock™ Light Cure Flowable Composite Kit
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869843000277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869843000277008698430002778698430002770869843000277

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
077801124
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042124875OSE8007-7772026-01-28
00810042124844OSEX009-0062025-11-26
00810042124851OSEX009-0072025-11-26
00810042124868OSEX009-0082025-11-26
00869843000239Depend-On0169-0002016-07-29
00869843000291OSE 8oz. Orthodontic Etching Gel - Blue240M-L002018-06-13
00810042124745OSE0202-0072023-08-11
00810042124752OSE0202-0082023-08-11
00810042124769OSE0202-0092023-08-11
00810042124738OSE0580-0122023-07-20
00810042124547OSE0202-F2023-06-21
00810042124554OSE0202-G2023-06-21
00810042124561OSE0202-H2023-06-21
00810042124578OSE0202-J2023-06-21
00810042124585OSE0202-K2023-06-21
00810042124592OSE0202-W2023-06-21
00810042124608OSE0202-Y2023-06-21
00810042124639OSE0202-N2023-06-21
00810042124646OSE0202-P2023-06-21
00810042124653OSE0202-V2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291971Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291988Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292022Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292039Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292046Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292053Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292060Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292077Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292084Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292091Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208006605SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-23
07615208006162SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006179SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006209SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006216SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006247SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006254SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006261SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22