Macro-Lock Oval Intro Kit B

FDA UDI

Class I (US FDA UDI)

by Recherches Techniques Dentaires

Identity

Trade Name: MACRO-LOCK OVAL INTRO KIT B FDA UDI
Generic Name: Endodontic enlarger, reusable FDA UDI
Model / Reference: 46900004 FDA UDI

Identifiers

Catalog Number: 46900004 FDA UDI
Primary DI / UDI-DI: ERTD46900004013 FDA UDI
FDA Product Code: DZA FDA UDI
ELR FDA UDI
GMDN Term: Endodontic enlarger, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4130 FDA UDI
872.3810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Category: Root canal post, preformed Pin/post dental drill bit Endodontic enlarger, reusable

Macro-Lock Oval Intro Kit B by Recherches Techniques Dentaires — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Recherches Techniques Dentaires

Sources (1)

FDA UDI c371f591-4991-4940-857c-ea7f62e626af 33 fields · synced Jun 6, 2026