Identity
- Trade Name
- Osstem Mixing Tip FDA UDI
- Generic Name
- Dental impression material syringe, single-use FDA UDI
- Model / Reference
- OMTL300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800040686231 FDA UDI
- FDA Product Code
- EID FDA UDI
- GMDN Term
- Dental impression material syringe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression material syringe, single-use
Osstem Mixing Tip by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material syringe, single-use.
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- CanalPro Color Syringes — ZOGEAR Medical Co., Ltd. · Class I
- Britedent — BRIGHT SUPPLY INC · Class I
- Bosworth — Keystone Industries · Class I
- Mixing Tips — Kettenbach GmbH & Co. KG · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI 392d37fa-1b07-4c40-a80e-dd49c21c0dc0 32 fields · synced May 30, 2026