DLC Step Drill 2.3/2.0mm (6-13mmL)

FDA UDI

Class II (US FDA UDI)

by Implant Direct Sybron Manufacturing Llc

Identity

Trade Name: DLC Step Drill 2.3/2.0mm (6-13mmL) FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Model / Reference: SD2.3CS FDA UDI

Identifiers

Catalog Number: SD2.3CS FDA UDI
Primary DI / UDI-DI: 10841307124726 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

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, reusable

DLC Step Drill 2.3/2.0mm (6-13mmL) by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K200265 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: Implant Direct Sybron Manufacturing Llc

Sources (1)

FDA UDI dd2cf827-3fa0-4620-9f71-0e834f4fd4f2 36 fields · synced Jun 8, 2026