Identity
- Trade Name
- Hader Bar® Impression Coping FDA UDI
- Generic Name
- Dental implant abutment impression cap FDA UDI
- Device Name
- Seats securely onto a Hader Bar while the impression is being made. Ensures accurate positioning of the Hader Bar Processing Jig in the impression even if the bar is worn or over polished. FDA UDI
- Model / Reference
- 810017 FDA UDI
- Description
- Seats securely onto a Hader Bar while the impression is being made. Ensures accurate positioning of the Hader Bar Processing Jig in the impression even if the bar is worn or over polished. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549118272 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Dental implant abutment impression cap 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant abutment impression cap
Hader Bar® Impression Coping 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 4d640a1b-01a8-4185-85ac-c4f57d614bc8 34 fields · synced May 30, 2026