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-U E-Series FlipTop™ Casstte - Utility R245 Cone Socket Mirror Handle R256 Anterior Periotome R258 Posterior Periotome R437 Lucas 86 T018FM Silicone Finger Mat T050 #5 Mirror (15/16") T100 Caewood-Minnesota Retractor T103 Seldin 34 Root Elevator T235 Aspirating Anesthetic Syringe Medium T714 Crile Wood Tungsten Carbide Needle Holder (15cm) T730 Friedman Bone Rongeur T740 Prichard Periosteal Elevator T790 150 Extra Grip Extracting Forceps T792 151 Extra Grip Extracting Forceps T800 Iris Curved Scissors (11.5cm) T820 LaGrange Scissors (11.5cm) FDA UDI
Model / Reference: R922 PDT Oral Surgery Kit FDA UDI
Description: Kit Includes: T015E-U E-Series FlipTop™ Casstte - Utility R245 Cone Socket Mirror Handle R256 Anterior Periotome R258 Posterior Periotome R437 Lucas 86 T018FM Silicone Finger Mat T050 #5 Mirror (15/16") T100 Caewood-Minnesota Retractor T103 Seldin 34 Root Elevator T235 Aspirating Anesthetic Syringe Medium T714 Crile Wood Tungsten Carbide Needle Holder (15cm) T730 Friedman Bone Rongeur T740 Prichard Periosteal Elevator T790 150 Extra Grip Extracting Forceps T792 151 Extra Grip Extracting Forceps T800 Iris Curved Scissors (11.5cm) T820 LaGrange Scissors (11.5cm) FDA UDI

Identifiers

Catalog Number: R922 FDA UDI
Primary DI / UDI-DI: 00813677024886 FDA UDI
FDA Product Code: EAX FDA UDI
EMO FDA UDI
EMK FDA UDI
EIF FDA UDI
EMJ FDA UDI
EIC FDA UDI
EMH FDA UDI
EMG FDA UDI
EGN FDA UDI
FSM FDA UDI
HXK 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
888.4540 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 Suturing needle holder, reusable Dental elevator, tooth/root Tooth extraction forceps

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

Similar devices

Also classified as Dental irrigation/aspiration syringe.

Vivid HypoJect 3cc — PEARSON DENTAL SUPPLIES, INC. · Class II
American Eagle Instruments — American Eagle Instruments · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
CLEARJET AIR WATER SYRINGE TIPS 250/bag STD 76mm CLEAR — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
CanalPro — Coltene/Whaledent Inc. · Class I
Henry Schein — HENRY SCHEIN, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: PDT, Inc.

Sources (1)

FDA UDI e1de2c0b-8f7b-41dd-b909-e9a0222225f5 34 fields · synced Jun 9, 2026