Identity
- Trade Name
- Genesis FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Cover Screw FDA UDI
- Model / Reference
- G21100 FDA UDI
- Description
- Cover Screw FDA UDI
Identifiers
- Catalog Number
- G21100 FDA UDI
- Primary DI / UDI-DI
- D768G211000 FDA UDI
- 510(k) Number
- K101545 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental implant suprastructure, temporary, preformed, single-use
This Genesis device is a prefabricated dental implant suprastructure, designed to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration during the oral soft-tissue healing and sculpturing period. It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in various shapes, sizes, and materials.
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K101545 also covers:
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
- Genesis — Keystone Dental Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keystone Dental Inc.
Sources (1)
- FDA UDI 5230592b-17d3-4060-bb1d-6aa8775f223a 37 fields · synced Jun 29, 2026