Identity
- Trade Name
- ERA® DO SP Basic Kit w/ Tools SS FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- Resilient precision attachment. Kit Contains: Three small post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange) 2 metal jackets, 2 Alignment handles, 2 blockout spacers, 1 of each pilot drill, countersink bur, core cutter bur and seating tool FDA UDI
- Model / Reference
- 811410 FDA UDI
- Description
- Resilient precision attachment. Kit Contains: Three small post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange) 2 metal jackets, 2 Alignment handles, 2 blockout spacers, 1 of each pilot drill, countersink bur, core cutter bur and seating tool FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549101809 FDA UDI
- 510(k) Number
- K913348 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Resilient dental precision attachment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
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
ERA® DO SP Basic Kit w/ Tools SS by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K913348 also covers:
- ERA® 0° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 0° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 11° DO Large Post Female SS — Sterngold Dental LLC
- ERA® 11° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 11° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 17° DO Large Post Female SS — Sterngold Dental LLC
- ERA® 17° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 17° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 5° DO Large Post Attachment SS — Sterngold Dental LLC
- ERA® 5° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 5° DO Small Post Female SS — Sterngold Dental LLC
- ERA® DO SP Master Kit w/ Tools SS — Sterngold Dental LLC
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 9fe8b67d-0bdb-4dd0-bc60-9dd9a1deb78f 36 fields · synced May 30, 2026