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DLC Cortical Bone Drill 7.0mmD Implant

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name
DLC Cortical Bone Drill 7.0mmD Implant FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Model / Reference
CBD7.0C FDA UDI

Identifiers

Catalog Number
CBD7.0C FDA UDI
Primary DI / UDI-DI
10841307124931 FDA UDI
510(k) Number
K200265 FDA UDI
FDA Product Code
DZI FDA UDI
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, reusable

DLC Cortical Bone Drill 7.0mmD Implant by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, reusable.

Cleared under the same submission

K200265 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implant Direct Sybron Manufacturing Llc

Sources (1)

  • FDA UDI c5c14a01-b6eb-492d-9e5f-d5bbc0186d63 35 fields · synced May 30, 2026