Identity
- Trade Name
- OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS FDA UDI
- Generic Name
- Dental amalgam mixer FDA UDI
- Model / Reference
- HYMIX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000995830 FDA UDI
- FDA Product Code
- EFD FDA UDI
- GMDN Term
- Dental amalgam mixer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental amalgam mixer
Osstem Implant Co., Ltd. Chair Business by OSSTEM IMPLANT Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental amalgam mixer.
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- Techno — DMG America LLC · Class I
- Biodentine Mixer — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
- 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- TPC — TPC ADVANCE TECHNOLOGY, INC. · Class I
- VIALMIX®RFID — LANTHEUS MEDICAL IMAGING, Inc. · 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 f8b1f94b-9182-4b53-ba84-e5a8a68a447a 32 fields · synced Jun 6, 2026