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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: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R245) Cone Socket Mirror Handle (R432) Slade Blade™ 1 (R433) Slade Blade™ 2 (R434) Slade Blade™ 3 (R435) Slade Blade™ 4 (R436) Slade Blade™ 5 (T050) #5 Mirror (15/16") (T704) Scalpel Handle (T710) Castroviejo Straight Tungsten Carbide Needle Holder (14cm) (T740) Prichard Periosteal Elevator FDA UDI
Model / Reference
R925 PDT Bone Grafting Kit FDA UDI
Description
Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R245) Cone Socket Mirror Handle (R432) Slade Blade™ 1 (R433) Slade Blade™ 2 (R434) Slade Blade™ 3 (R435) Slade Blade™ 4 (R436) Slade Blade™ 5 (T050) #5 Mirror (15/16") (T704) Scalpel Handle (T710) Castroviejo Straight Tungsten Carbide Needle Holder (14cm) (T740) Prichard Periosteal Elevator FDA UDI

Identifiers

Catalog Number
R925 FDA UDI
Primary DI / UDI-DI
00813677024893 FDA UDI
FDA Product Code
HXK FDA UDI
EAX FDA UDI
EJB FDA UDI
EMK FDA UDI
GDZ FDA UDI
EMJ FDA UDI
FSM FDA UDI
GMDN Term
Dental mirror, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
872.4565 FDA UDI
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Instrument tray, reusableSuturing needle holder, reusableDental elevator, tooth/rootPeriodontal curette

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

Similar devices

Also classified as Dental mirror, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PDT, Inc.

Sources (1)

  • FDA UDI eab57d94-c1b9-4037-a5f7-7b7398b335ba 34 fields · synced Jun 9, 2026