Identity
- Trade Name
- Hader Bar® Starter Kit. FDA UDI
- Generic Name
- Bar dental precision attachment FDA UDI
- Device Name
- A Hader Bar is a type of denture attachment that improves the retention and stability of a denture, particularly overdentures (dentures supported by implants). It involves a metal bar placed on the implants, with a plastic or metal bar fitting over it within the denture. The kit includes 2 bars, 6 yellow riders, 6 fabricating riders, 1 seating tool. FDA UDI
- Model / Reference
- 810001 FDA UDI
- Description
- A Hader Bar is a type of denture attachment that improves the retention and stability of a denture, particularly overdentures (dentures supported by implants). It involves a metal bar placed on the implants, with a plastic or metal bar fitting over it within the denture. The kit includes 2 bars, 6 yellow riders, 6 fabricating riders, 1 seating tool. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549115783 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Bar dental precision attachment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bar dental precision attachment
Hader Bar® Starter Kit. by Sterngold Dental LLC — 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
- Sterngold Dental LLC
Sources (1)
- FDA UDI bafb35ce-221e-40cb-a0d8-f4ce53726142 34 fields · synced Jun 1, 2026