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GBR System Bone Screw

FDA UDI

Class II (US FDA UDI)

by Jeil Medical Corporation

Identity

Trade Name
GBR System Bone Screw FDA UDI
Generic Name
Orthodontic anchoring screw FDA UDI
Model / Reference
14-AT-003G-25 FDA UDI

Identifiers

Primary DI / UDI-DI
08809282812057 FDA UDI
510(k) Number
K143730 FDA UDI
FDA Product Code
DZL FDA UDI
GMDN Term
Orthodontic anchoring screw 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

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic anchoring screw

GBR System Bone Screw by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic anchoring screw.

Cleared under the same submission

K143730 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jeil Medical Corporation

Sources (1)

  • FDA UDI a674dfa0-38c6-4d03-9005-894e9b7e5f36 33 fields · synced May 30, 2026