Stern EX Acid Etched Implant NP 3.3x15.0mm, Direct Delivery, Ti
Basic Information
- Brand Name
- Stern EX Acid Etched Implant NP 3.3x15.0mm, Direct Delivery, Ti
- Primary DI
- 00841549108990
- Version / Model
- 901658
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-23
- Public Version
- 8
- Public Version Date
- 2023-07-27
- Public Version Status
- Update
- Public Device Record Key
- da539d22-9607-4f51-97b4-e10d752af28c
- Distribution End Date
- 2023-07-26
Device Description
The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded, root-form endosseous implants that will be available is a variety of sizes to suit individual usedpatient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The proposed implants are compatible with standard, regular platform (4. lmm), external-hex (antirotational) abutments such as the currently marketed Sterngold-ImplaMed, Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants. Intended for implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55848 | Screw endosteal dental implant, one-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841549108990 | GS1 |
Customer Contacts
- Phone
- 401-871-3489
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023580 | 000 |