Identity
- Trade Name
- ERA® DO SP Master Kit w/ Tools SS FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- This part contains: Five small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. FDA UDI
- Model / Reference
- 811400 FDA UDI
- Description
- This part contains: Five small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549101748 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
- 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
Category: Resilient dental precision attachment
ERA® DO SP Master Kit w/ Tools SS by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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® Drill & Tap Attachment — 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 6f27c393-4585-41be-abf1-24b7915e535f 35 fields · synced Jun 1, 2026