PDT, Inc.

FDA UDI

Class I (US FDA UDI)

by PDT, Inc.

Identity

Trade Name: PDT, Inc. FDA UDI
Generic Name: Endodontic plugger FDA UDI
Device Name: Kit Includes: T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std Divider R245 Mirror Handle (Cone-Socket) R311 DG 16 Explorer R312 D11 Endo Spreader R314 1/3 Endo Plugger R315 5/7 Endo Plugger R316 9/11 Endo Plugger R317 Glick 1 R318 31L Endo Excavator T045 Locking Cotton Plier T046 Articulating paper forceps MILLER T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T235 Aspirating Anesthetic Syringe Medium T785 Rubberdam clamp forceps IVORY FDA UDI
Model / Reference: R982 Endo Kit FDA UDI
Description: Kit Includes: T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std Divider R245 Mirror Handle (Cone-Socket) R311 DG 16 Explorer R312 D11 Endo Spreader R314 1/3 Endo Plugger R315 5/7 Endo Plugger R316 9/11 Endo Plugger R317 Glick 1 R318 31L Endo Excavator T045 Locking Cotton Plier T046 Articulating paper forceps MILLER T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T235 Aspirating Anesthetic Syringe Medium T785 Rubberdam clamp forceps IVORY FDA UDI

Identifiers

Catalog Number: R982 FDA UDI
Primary DI / UDI-DI: 00813677024480 FDA UDI
FDA Product Code: FSM FDA UDI
EKB FDA UDI
EAX FDA UDI
EJB FDA UDI
EKK FDA UDI
EKR FDA UDI
EKC FDA UDI
EIC FDA UDI
EJG FDA UDI
GMDN Term: Endodontic plugger FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
872.4565 FDA UDI
872.6300 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 Dental excavator, reusable

PDT, Inc. by PDT, Inc. — 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: PDT, Inc.

Sources (1)

FDA UDI 7d210ba9-4624-4859-88f2-a99d54779ff2 34 fields · synced Jun 9, 2026