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Zoll Dental

FDA UDI

Class I (US FDA UDI)

by Zoll-Dental

Identity

Trade Name
ZOLL DENTAL FDA UDI
Generic Name
Dental amalgam carrier FDA UDI
Device Name
Amalgam Well, Standard (30 mm x h 30 mm) FDA UDI
Model / Reference
Z-4944 FDA UDI
Description
Amalgam Well, Standard (30 mm x h 30 mm) FDA UDI

Identifiers

Primary DI / UDI-DI
00840105223207 FDA UDI
FDA Product Code
EKI FDA UDI
GMDN Term
Dental amalgam carrier 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

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: Dental amalgam carrier

Zoll Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental amalgam carrier.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll-Dental

Sources (1)

  • FDA UDI 24cf17f1-bdb6-4ffe-9343-b6f545954d24 34 fields · synced May 31, 2026