PDT, Inc.

FDA UDI

Class I (US FDA UDI)

by PDT, Inc.

Identity

Trade Name: PDT, Inc. FDA UDI
Generic Name: Dental surgical scissors FDA UDI
Device Name: Kit Includes: T015E-U FlipTop™ Cassette 'E' – Utility T018FM Silicone Finger Mat 10.75”x 8” R245 Mirror Handle (Cone-Socket) R437 Lucas 86 T040 Tweezers COLLEGE T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T080 Tissue pliers ADSON T100 Retractor Caewood Minnesota 16 T102S Root elevator Seldin No. 301 straight Smooth Handle T104S Root elevator Seldin 34S Smooth Handle T118 Periosteal Elevator Molt 9 Hollow handle T235 Aspirating Anesthetic Syringe Medium T320 Elevator Fragment Ejector/Root Tip Pick, HEIDBRINK T704 Scalpel handle T714 TC Needle Holder CRILE WOOD T813 Scissors Goldman-Fox curved 12.5 T850 Miller-Colburn Bone File #1, Serrated FDA UDI
Model / Reference: R983 Rev C Basic Extraction Kit FDA UDI
Description: Kit Includes: T015E-U FlipTop™ Cassette 'E' – Utility T018FM Silicone Finger Mat 10.75”x 8” R245 Mirror Handle (Cone-Socket) R437 Lucas 86 T040 Tweezers COLLEGE T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T080 Tissue pliers ADSON T100 Retractor Caewood Minnesota 16 T102S Root elevator Seldin No. 301 straight Smooth Handle T104S Root elevator Seldin 34S Smooth Handle T118 Periosteal Elevator Molt 9 Hollow handle T235 Aspirating Anesthetic Syringe Medium T320 Elevator Fragment Ejector/Root Tip Pick, HEIDBRINK T704 Scalpel handle T714 TC Needle Holder CRILE WOOD T813 Scissors Goldman-Fox curved 12.5 T850 Miller-Colburn Bone File #1, Serrated FDA UDI

Identifiers

Catalog Number: R983 Rev C FDA UDI
Primary DI / UDI-DI: 00813677025135 FDA UDI
FDA Product Code: EJY FDA UDI
EIF FDA UDI
EMK FDA UDI
EAX FDA UDI
GDZ FDA UDI
EGN FDA UDI
FSM FDA UDI
EJB FDA UDI
HXK FDA UDI
EMI FDA UDI
EMJ FDA UDI
EIC FDA UDI
GMDN Term: Dental surgical scissors 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 Surgical soft-tissue manipulation forceps, tweezers-like, reusable Bone file/rasp, manual, reusable

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 39279e1c-cbe9-40eb-a668-f23a4e506605 34 fields · synced Jun 9, 2026