FDA UDI
In Commercial Distribution
🇺🇸 United States
Inlay / Onlay Styx
DI: D8374520200
·
Model: TIPS 12 pk - Inlay / Onlay Styx White
·
Taub Products
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inlay / Onlay Styx
- Primary DI
- D8374520200
- Version / Model
- TIPS 12 pk - Inlay / Onlay Styx White
- Catalog Number
- 45-2020
- Company Name
- Taub Products
- Labeler DUNS
- 067488114
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-10
- Public Version
- 3
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 38397bee-909d-44e8-ad6b-d953b14ec3b0
Device 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).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64304 | Manual non-rotary dental instrument handle | A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8374520200 | HIBCC |