Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003963832

FEI Number

3003963832

Entity Name

PDT, INC.

City/State/Country

MSLA, MT, US

Establishment Address

8275 Highway 10 W, MSLA, MT 59808, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PDT, INC. (Owner Number: 9041208)

Owner / Operator Contact Address

8275 HWY 10 W, Missoula, MT 59808, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PDT, Inc. PDT PDT, Inc. PDT PDT PDT WindowTray PDT Miller Articulating Forceps PDT, Inc. Bone Aspirator PDT PDT, Inc. PDT PDT, Inc. PDT, Inc. PDT PDT, Inc. PDT, Inc. PDT, Inc. PDT FlipTop Cassette PDT PDT PDT Root Elevator Heidbrink Periosteal Elevator Prichard Root Elevator Lindo Levien Root Elevator Apical Flohr PDT Root Elevator Seldin Root Elevator Cryer PDT, Inc. PDT, Inc. PDT PDT, Inc. PDT PDT, Inc. PDT, Inc. PDT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-01-06
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-12-10
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2012-01-06
EIG	Retractor, All Types	Dental	Class 1	872.4565	2015-12-10
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2015-12-11
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2015-12-10
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2015-12-10
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2015-12-10
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2004-02-10
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2017-09-21
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2015-12-11
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2012-01-06
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2015-12-10
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2015-12-10
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2024-07-02
EMR	File, Periodontic	Dental	Class 1	872.4565	2012-01-06
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2012-01-06
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2024-07-17
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2017-12-14
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2015-12-10
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2024-07-02
EKB	Explorer, Operative	Dental	Class 1	872.4565	2000-04-28
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2012-01-06
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2017-12-14
MXP	Bone Particle Collector	Ear, Nose, Throat	Class 1	874.4800	2023-12-20
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2000-04-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-10-08
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2015-12-10
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2015-12-10
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2015-12-11
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2015-12-10
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2017-12-14
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2012-01-06
EIS	Remover, Crown	Dental	Class 1	872.4565	2015-12-10
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2012-01-06
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2024-07-02
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2024-07-02
EKE	Curette, Operative	Dental	Class 1	872.4565	2015-12-11
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2012-01-06
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-05-08
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2015-12-10
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2015-12-11
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2015-12-10
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2012-01-06
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	2012-01-06
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2015-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PDT, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003963832. Last updated year: 2026. Please use registration number 3003963832 when referencing this establishment in official correspondence.