Identity
- Trade Name
- MOR®-A Implant FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- 3.0 x 15mm, Ti. The MOR® is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with three body diameters, 2.1 mm, 2.4 mm, and 3.0mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR® implant body is designed with an O-ball denture connection or with a tapering post connection (MOR-A) which may also be used for crown and bridge replacement. FDA UDI
- Model / Reference
- 901496 FDA UDI
- Description
- 3.0 x 15mm, Ti. The MOR® is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V – ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with three body diameters, 2.1 mm, 2.4 mm, and 3.0mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR® implant body is designed with an O-ball denture connection or with a tapering post connection (MOR-A) which may also be used for crown and bridge replacement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549108303 FDA UDI
- 510(k) Number
- K171728 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, one-piece
MOR®-A Implant by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171728 also covers:
- MOR® Implant 2.1 X 18mm, Ti — Sterngold Dental LLC
- MOR® Implant 2.4 X 18mm, Ti — Sterngold Dental LLC
- MOR® Implant 3.0 X 10mm, Ti — Sterngold Dental LLC
- MOR® Implant 3.0 X 13mm, Ti — Sterngold Dental LLC
- MOR® Implant 3.0 X 15mm, Ti — Sterngold Dental LLC
- MOR® Implant 3.0 X 18mm, Ti — Sterngold Dental LLC
- MOR®-A Implant 3.0 x 10mm, Ti — Sterngold Dental LLC
- MOR®-A Implant 3.0 x 13mm, Ti — Sterngold Dental LLC
- MOR®-A Implant 3.0 x 18mm, Ti — Sterngold Dental LLC
- MOR®-A Temporization Cap — Sterngold Dental LLC
- PUR® Straight Abutment Slim 1.5mm Cuff (B), Ti — Sterngold Dental LLC
- PUR® Straight Abutment Slim 3mm Cuff (B), Ti — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 1029923a-15c0-4401-afcd-10b2ad92d592 35 fields · synced May 30, 2026