FDA UDI
In Commercial Distribution
🇺🇸 United States
Stern Root Anchor® 10 Root Mini Refill Kit Ti
DI: 00841549106743
·
Model: 833095
·
STERNGOLD DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stern Root Anchor® 10 Root Mini Refill Kit Ti
- Primary DI
- 00841549106743
- Version / Model
- 833095
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-15
- Public Version
- 7
- Public Version Date
- 2023-03-24
- Public Version Status
- Update
- Public Device Record Key
- 9c9d39e8-88eb-4cdb-bd5c-229e09dc3abb
Device Description
The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The Stern Anchor Male (Standard, short, oversize, extra oversize), the Stern Anchor Denture Cap. Intended to be used in attachment dentistry for stabilization and retention of removable appliances in the mouth. The 10 root kit contains-10 females, 20 white retention males, 10 transfer males, 10 caps, without bur.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38603 | Resilient dental precision attachment | A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841549106743 | GS1 |
Customer Contacts
- Phone
- 401-871-3489
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950213 | 000 |