Identity
- Trade Name
- DenQ Sub SLA Fixture II FDA UDI
- Generic Name
- Basket endosteal dental implant, two-piece FDA UDI
- Device Name
- 6.8x8.0, Bone level FDA UDI
- Model / Reference
- DSSDW70080 FDA UDI
- Description
- 6.8x8.0, Bone level FDA UDI
Identifiers
- Catalog Number
- DSSDW70080 FDA UDI
- Primary DI / UDI-DI
- 08800131002827 FDA UDI
- 510(k) Number
- K240977 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Basket endosteal dental implant, two-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
MR Conditional FDA UDI
Category: Basket endosteal dental implant, two-piece
DenQ Sub SLA Fixture II by Denq — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basket endosteal dental implant, two-piece.
- Versatile Implant — Surgikor, LLC · Class II
- MIS C1 — MIS Implants Technologies Ltd. · Class II
- Straight Drill with Stopper without Irrigation — Surgikor, LLC · Class I
- 15˚ Angled Anatomic Abutment — Surgikor, LLC · Class II
- Implant Hand Driver — Surgikor, LLC · Class I
- MIS SEVEN — MIS Implants Technologies Ltd. · Class II
- Fixation Implant Pack — Surgikor, LLC · Class II
- Solution5 Implant — Surgikor, LLC · Class II
Cleared under the same submission
K240977 also covers:
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
- DenQ Sub SLA Fixture I — Denq
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Denq
Sources (1)
- FDA UDI e11cc488-888b-42f2-85be-4af937e0d8f2 37 fields · synced Jun 1, 2026