Karl Schumacher

FDA UDI

Class I (US FDA UDI)

by Karl Schumacher Dental, Llc

Identity

Trade Name: Karl Schumacher FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: Kirkland Perio Chisel, Hvy / X-Hvy, #6 FDA UDI
Model / Reference: BCH6013L FDA UDI
Description: Kirkland Perio Chisel, Hvy / X-Hvy, #6 FDA UDI

Identifiers

Primary DI / UDI-DI: 00842517105751 FDA UDI
FDA Product Code: EML FDA UDI
GMDN Term: Bone cutter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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: Bone cutter

Karl Schumacher by Karl Schumacher Dental, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone cutter.

Zimmer Persona Knee System — Zimmer, Inc. · Class II
Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
Novel — ALPHATEC SPINE, INC. · Class I
Battalion — ALPHATEC SPINE, INC. · Class I
Intervertebral Disc Preparation Instruments — ALPHATEC SPINE, INC. · Class I
Battalion — ALPHATEC SPINE, INC. · Class I
IdentiTi — ALPHATEC SPINE, INC. · Class I
Park Dental Research Corp. — Park Dental Research Corp · Class II

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Karl Schumacher Dental, Llc

Sources (1)

FDA UDI 61690304-444a-4ec0-9b74-86f209ef6b4a 34 fields · synced May 30, 2026