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: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (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 (T046) Miller Articulating Paper Forceps (T047) Endo Locking Pliers (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T784) Ainsworth Rubber Dam Punch Forceps (T785) Ivory Rubber Dam Clamp Forceps (T786) Rubber Dam Frame (T863) Small Parts Basket FDA UDI
Model / Reference: R943 PDT Endo Kit FDA UDI
Description: Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (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 (T046) Miller Articulating Paper Forceps (T047) Endo Locking Pliers (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T784) Ainsworth Rubber Dam Punch Forceps (T785) Ivory Rubber Dam Clamp Forceps (T786) Rubber Dam Frame (T863) Small Parts Basket FDA UDI

Identifiers

Catalog Number: R943 FDA UDI
Primary DI / UDI-DI: 00813677024985 FDA UDI
FDA Product Code: EKB FDA UDI
EAX FDA UDI
FSM FDA UDI
EJB FDA UDI
EKK FDA UDI
EKR FDA UDI
EKC FDA UDI
EIC FDA UDI
EJG FDA UDI
EJE FDA UDI
MXP 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
872.6300 FDA UDI
874.4800 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 Dental excavator, reusable

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

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HYGENIC — Coltene/Whaledent Inc. · Class I
Pomee — POMEE CORPORATION · 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: PDT, Inc.

Sources (1)

FDA UDI 3c1a803d-b8c1-4ab0-966a-b2cc27a641dc 34 fields · synced Jun 9, 2026