Zuga

FDA UDI

Class II (US FDA UDI)

by Zuga Medical, Inc.

Identity

Trade Name: Zuga FDA UDI
Generic Name: Dental soft-tissue coring punch, reusable FDA UDI
Device Name: Gum Punch FDA UDI
Model / Reference: GST-500-000 FDA UDI
Description: Gum Punch FDA UDI

Identifiers

Primary DI / UDI-DI: 00854382006910 FDA UDI
510(k) Number: K122664 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental soft-tissue coring punch, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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: Dental soft-tissue coring punch, reusable

Zuga by Zuga Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental soft-tissue coring punch, reusable.

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A. Titan Instruments — A.Titan Instruments · Class I
STOMA® — Storz am Mark GmbH · Class I
CIRCULAR KNIFE CMU 7.1mm — W.H. Holden, Inc. · Class I
BMT Medizintechnik GmbH — BMT Medizintechnik GmbH · Class I
TREPHINE-5mm-LATCH TYPE — W.H. Holden, Inc. · Class I

Cleared under the same submission

K122664 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: Zuga Medical, Inc.

Sources (1)

FDA UDI dd7f516b-c1d0-4160-8c3a-63d2c05f6c21 35 fields · synced Jun 8, 2026