PDT, Inc.

FDA UDI

Class I (US FDA UDI)

by PDT, Inc.

Identity

Trade Name: PDT, Inc. FDA UDI
Generic Name: Manual dental scaler, reusable FDA UDI
Device Name: Kit Includes: T005A-F A-Series FlipTop™ Cassette - Fixed Rack 5 R630 Pineyro Arch™ Ti 1 R631 Pineyro Arch™ Ti 2 R632 Pineyro Arch™ Ti 3 R633 Pineyro Arch™ Ti 4 FDA UDI
Model / Reference: R930 Pineyro Arch™ Implant Kit with Cassette FDA UDI
Description: Kit Includes: T005A-F A-Series FlipTop™ Cassette - Fixed Rack 5 R630 Pineyro Arch™ Ti 1 R631 Pineyro Arch™ Ti 2 R632 Pineyro Arch™ Ti 3 R633 Pineyro Arch™ Ti 4 FDA UDI

Identifiers

Catalog Number: R930 FDA UDI
Primary DI / UDI-DI: 00813677024923 FDA UDI
FDA Product Code: FSM FDA UDI
EMN FDA UDI
GMDN Term: Manual dental scaler, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
872.4565 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Instrument tray, reusable Manual dental scaler, reusable

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

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NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
Pomee — POMEE CORPORATION · 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 6a5d8acd-b99b-4d5b-b824-cfadec24bb8f 34 fields · synced Jun 9, 2026