PDT, Inc.

FDA UDI

Class I (US FDA UDI)

by PDT, Inc.

Identity

Trade Name: PDT, Inc. FDA UDI
Generic Name: Periodontal curette FDA UDI
Device Name: Kit Includes: R067 Columbia 4L-4R R138R Montana Jack® Rigid R120 Montana 4-5™ Scaler R030R Amazing Gracey™ 15-16 Rigid T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7 R028R Amazing Gracey™ 13-14 Rigid FDA UDI
Model / Reference: R978 Gross Debridement Kit FDA UDI
Description: Kit Includes: R067 Columbia 4L-4R R138R Montana Jack® Rigid R120 Montana 4-5™ Scaler R030R Amazing Gracey™ 15-16 Rigid T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7 R028R Amazing Gracey™ 13-14 Rigid FDA UDI

Identifiers

Catalog Number: R978 FDA UDI
Primary DI / UDI-DI: 00813677024510 FDA UDI
FDA Product Code: EMS FDA UDI
EMN FDA UDI
FSM FDA UDI
GMDN Term: Periodontal curette FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
878.4800 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 Periodontal curette 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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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 6a564c33-f4a8-449b-b9f5-0df601ba7030 34 fields · synced Jun 9, 2026