FDA UDI
In Commercial Distribution
🇺🇸 United States
SternSnap Angled Attachment
DI: 00841549110382
·
Model: 904123
·
STERNGOLD DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SternSnap Angled Attachment
- Primary DI
- 00841549110382
- Version / Model
- 904123
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-23
- Public Version
- 7
- Public Version Date
- 2023-03-24
- Public Version Status
- Update
- Public Device Record Key
- a8fab80d-3314-462d-b2ff-0a6534d3e0fe
Device Description
Introducing the new Stern SNAP Angled Overdenture Implant Abutment System, compatible with all popular implant systems. Its Innovative Two-piece design allows the SNAP Angled to perform True Angle Correction of up 20 degrees on divergent implants, without the need to rely on a hinging attachment. The System features a New Maximum Durability Cap, (available in 1lb, 2lb, and 3lb,) that does not require a housing, making for a low profile of only 2.5mm and requiring less space needed in the denture. The Stern SNAP is an Innovative, Predictable, and Economical solution for stabilizing your patients’ denture.
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 | 00841549110382 | GS1 |
Customer Contacts
- Phone
- 401-871-3489
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150250 | 000 |