PDT, Inc.

FDA UDI

Class I (US FDA UDI)

by PDT, Inc.

Identity

Trade Name: PDT, Inc. FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6 Discoid-Cleoid Carver (R284) Hollenback 1/2-3 Carver (R286) G2 Thin Composite (R287) G3 Thin Composite (R333) 27-29 Burnisher (R336) Calcium Hydroxide Placer (R347) 0-1 Blacks Plugger (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T356) Amalgam Well (T800) Iris Curved Scissors (11.5cm) FDA UDI
Model / Reference: R937 PDT Total Restorative Kit FDA UDI
Description: Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R138) Montana Jack™ (R223) 23 Explorer-12 Probe (R245) Cone Socket Mirror Handle (R269) 3-6 Discoid-Cleoid Carver (R284) Hollenback 1/2-3 Carver (R286) G2 Thin Composite (R287) G3 Thin Composite (R333) 27-29 Burnisher (R336) Calcium Hydroxide Placer (R347) 0-1 Blacks Plugger (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (R534) IPC-T Gold Line™ (Composite Sculpting System) (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T356) Amalgam Well (T800) Iris Curved Scissors (11.5cm) FDA UDI

Identifiers

Catalog Number: R937 FDA UDI
Primary DI / UDI-DI: 00813677024978 FDA UDI
FDA Product Code: EAX FDA UDI
FSM FDA UDI
EMN FDA UDI
EJY FDA UDI
EKB FDA UDI
EIX FDA UDI
EKI FDA UDI
EJB FDA UDI
EKH FDA UDI
EKJ FDA UDI
EIY FDA UDI
EIC FDA UDI
EKG FDA UDI
DZN FDA UDI
EGN FDA UDI
EKC FDA UDI
GMDN Term: Instrument tray, 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 Surgical soft-tissue manipulation forceps, tweezers-like, reusable Manual dental scaler, reusable Dental surgical probe, reusable

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

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Also classified as Dental amalgam well.

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OSUNG MND — Osung Mnd Co., Ltd. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
PDT, Inc. — PDT, Inc. · 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 c6e6d51a-3aed-4501-bee7-823112e7037c 34 fields · synced Jun 9, 2026