FDA UDI
In Commercial Distribution
🇺🇸 United States
Stern Snap® Retaining Cap Metal Free, Green, 3 pack
DI: 00841549110429
·
Model: 904135
·
STERNGOLD DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stern Snap® Retaining Cap Metal Free, Green, 3 pack
- Primary DI
- 00841549110429
- Version / Model
- 904135
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-07
- Public Version
- 1
- Public Version Date
- 2020-07-15
- Public Version Status
- New
- Public Device Record Key
- e4923a3f-7d77-41d8-891c-b7ad69e2e795
Device Description
The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The Stern Snap® attachment consists of a modified ball, which screws into an Abutment Base (alternatively the one-piece Stern Snap® Abutments may be screwed directly into an implant) and a retention cap, which is processed into the denture. The retention cap engages the outside of the ball shape and allows retention of the prosthesis to the 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 | 00841549110429 | GS1 |
Customer Contacts
- Phone
- 5082265660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150250 | 000 |