FDA.reportPublic FDA data

Osstem Mixing Tip

Primary DI
08800040686200
Brand
Osstem Mixing Tip
Company
Osstem Implant Co.,Ltd.
Model
OMTH100
Published
2022-12-08
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
EIDSyringe, Restorative And Impression Material

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800040686200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800040686200088000406862008800040686200

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, single-useA non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

Regulatory Flags#

DUNS number
694893867
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-09-04
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSK52025-04-24
08800000996042T2 PlusT2-CS-P2025-04-28
08800000996059T2 PlusT2-C-P2025-04-28
08800209338841Estar-ZEZEHTA2012M2024-12-03
08800209338865Estar-ZEZEHTA2014M2024-12-03
08800209338889Estar-ZEZEHTA2016M2024-12-03
08800209338902Estar-ZEZEHTA2018M2024-12-03
08800209338926Estar-ZEZEHTA2020M2024-12-03
08800209338940Estar-ZEZEHTA2022M2024-12-03
08800209338964Estar-ZEZEHTA2025M2024-12-03
08800209338988Estar-ZEZEHTA2030M2024-12-03
08800209339008Estar-ZEZEHTA3010M2024-12-03
08800209339022Estar-ZEZEHTA3012M2024-12-03
08800209339046Estar-ZEZEHTA3014M2024-12-03
08800209339060Estar-ZEZEHTA3016M2024-12-03
08800209339084Estar-ZEZEHTA3018M2024-12-03
08800209339107Estar-ZEZEHTA3020M2024-12-03
08800209339121Estar-ZEZEHTA3022M2024-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15
10371347008620Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10
10371347008637Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10