DenQ Sub SLA Fixture I

FDA UDI

Class II (US FDA UDI)

by Denq

Identity

Trade Name: DenQ Sub SLA Fixture I FDA UDI
Generic Name: Basket endosteal dental implant, two-piece FDA UDI
Device Name: 6.8x12.0, Bone level FDA UDI
Model / Reference: DSSW70120 FDA UDI
Description: 6.8x12.0, Bone level FDA UDI

Identifiers

Catalog Number: DSSW70120 FDA UDI
Primary DI / UDI-DI: 08800131000960 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Basket endosteal dental implant, two-piece

The DenQ Sub SLA Fixture I is a Basket endosteal dental implant, two-piece device designed to support and retain dental prosthesis in the mandible or maxilla. It features a sterile design made of alloplastic materials, including titanium, stainless steel, and ceramic, and has undergone significant improvements in terms of safety and functionality.

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Also classified as Basket endosteal dental implant, two-piece.

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Solution5 Implant — Surgikor, LLC · Class II

Cleared under the same submission

K240977 also covers:

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: Denq

Sources (1)

FDA UDI be27f7fa-1411-4957-8314-46ad505fa262 37 fields · synced Jun 22, 2026