Identity
- Trade Name
- Inlay / Onlay Styx Kit FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Prevents movement of the restoration during cementation. Allows for proper placement, positioning, and seating of inlays, onlays, crowns, with gentle and even distribution of pressure. Holds restoration securely during try-in, while contacts are checked with floss. Allows clear visibility of working field. Removes the need for touching the restoration with a glove. This prevents possible contamination of saliva or glove powder. Inlay/Onlay Styx are autoclavable. Tips are disposable (Single use per patient). FDA UDI
- Model / Reference
- 1x Inlay / Onlay Styx, 6x White Tips FDA UDI
- Description
- Prevents movement of the restoration during cementation. Allows for proper placement, positioning, and seating of inlays, onlays, crowns, with gentle and even distribution of pressure. Holds restoration securely during try-in, while contacts are checked with floss. Allows clear visibility of working field. Removes the need for touching the restoration with a glove. This prevents possible contamination of saliva or glove powder. Inlay/Onlay Styx are autoclavable. Tips are disposable (Single use per patient). FDA UDI
Identifiers
- Catalog Number
- 45-1020 FDA UDI
- Primary DI / UDI-DI
- D8374510200 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual non-rotary dental instrument handle
Inlay / Onlay Styx Kit by Taub Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Taub Products
Sources (1)
- FDA UDI 0553c2d3-d31c-4d53-a5bf-a84194fd85ef 34 fields · synced Jun 8, 2026