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GBR Screw

FDA UDI

Class II (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
GBR Screw FDA UDI
Generic Name
Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI
Device Name
GBR Screw / DBS1405 FDA UDI
Model / Reference
DBS1405 FDA UDI
Description
GBR Screw / DBS1405 FDA UDI

Identifiers

Primary DI / UDI-DI
08806169157232 FDA UDI
510(k) Number
K222367 FDA UDI
FDA Product Code
DZL FDA UDI
GMDN Term
Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental regeneration membrane fixation tack, non-bioabsorbable

GBR Screw by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental regeneration membrane fixation tack, non-bioabsorbable.

Cleared under the same submission

K222367 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentis Co. , Ltd

Sources (1)

  • FDA UDI c06bde99-b7b6-4430-b09f-042c13c8af62 34 fields · synced May 30, 2026