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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
3.7x8, Bone level FDA UDI
Model / Reference
DSSR35080 FDA UDI
Description
3.7x8, Bone level FDA UDI

Identifiers

Catalog Number
DSSR35080 FDA UDI
Primary DI / UDI-DI
08800131000038 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
Not 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
MRI Safety
MR Conditional FDA UDI

DenQ Sub SLA Fixture I by Denq — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K240977 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Denq

Sources (1)

  • FDA UDI fb666a8c-0643-4c19-97cb-8c213714f900 37 fields · synced May 30, 2026