SurgiMac

FDA UDI

Class I (US FDA UDI)

by Surgimac LLC

Identity

Trade Name: SurgiMac FDA UDI
Generic Name: Dental amalgam carrier FDA UDI
Device Name: Calcium-Hydroxide Placer, Hexa Series. FDA UDI
Model / Reference: 13-1257-H FDA UDI
Description: Calcium-Hydroxide Placer, Hexa Series. FDA UDI

Identifiers

Catalog Number: 13-1257-H FDA UDI
Primary DI / UDI-DI: D105SKU131257H02 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental amalgam carrier

SurgiMac by Surgimac LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental amalgam carrier.

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Power Dental USA — Power Dental USA, Inc. · Class I
Amalgam Carrier, Reg/Lrg — HU-FRIEDY MFG CO., LLC · Class I
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Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I

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

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Manufacturer

Manufacturer: Surgimac LLC

Sources (1)

FDA UDI 3e6fbf92-b66e-4dc9-aefd-165a2a0be114 34 fields · synced May 30, 2026