PDT, Inc.

FDA UDI

Class I (US FDA UDI)

by PDT, Inc.

Identity

Trade Name: PDT, Inc. FDA UDI
Generic Name: Dental mirror, reusable FDA UDI
Device Name: Kit Includes: T050 #5 Front Surface Mirror, Cone-Socket, (15/16') R245 Mirror Handle (Cone-Socket) R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R166 Explorer 5 T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 FDA UDI
Model / Reference: R972 RDH Exam Kit FDA UDI
Description: Kit Includes: T050 #5 Front Surface Mirror, Cone-Socket, (15/16') R245 Mirror Handle (Cone-Socket) R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R166 Explorer 5 T005A-F FlipTop™ Cassette 'A' - Fixed Rack 5 FDA UDI

Identifiers

Catalog Number: R972 FDA UDI
Primary DI / UDI-DI: 00813677024404 FDA UDI
FDA Product Code: EAX FDA UDI
EJB FDA UDI
EKB FDA UDI
EIX FDA UDI
FSM FDA UDI
GMDN Term: Dental mirror, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
878.4800 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

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

Yes

FDA UDI

Category: Instrument tray, reusable Dental surgical probe, reusable Dental mirror, reusable Manual non-rotary dental instrument handle

PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual non-rotary dental instrument handle.

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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: PDT, Inc.

Sources (1)

FDA UDI 72fca4bf-311c-40c1-86b1-9b1cacb8b749 34 fields · synced Jun 9, 2026