PDT, Inc.

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref R904

by PDT, Inc.

Identity

Trade Name: PDT3SAVER™ w/ Columbia 13-14, H5-L5 Mini, and Montana Jack® EUDAMED
PDT, Inc. FDA UDI
Generic Name: Manual dental scaler, reusable FDA UDI
Device Name: Hygiene instrument kits EUDAMED
Set Includes: R064 Columbia 13-14 R092 H5-L5 Mini R138 Montana Jack® FDA UDI
Model / Reference: R904 EUDAMED
R904 PDT3SAVER™ 2 FDA UDI
Description: Set Includes: R064 Columbia 13-14 R092 H5-L5 Mini R138 Montana Jack® FDA UDI

Identifiers

Catalog Number: R904 FDA UDI
Primary DI / UDI-DI: 00813677024800 EUDAMEDFDA UDI
Basic UDI-DI: 0813677021807WQ EUDAMED
FDA Product Code: EMN FDA UDI
EMS FDA UDI
EMDN Code: Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
GMDN Term: Manual dental scaler, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.4565 FDA UDI
Medical Purpose: Dental curettes/scalers for periodontal hygiene EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA 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: Periodontal curette Manual dental scaler, reusable

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

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Also classified as Manual dental scaler, reusable.

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DHP Scaler Instruments — Dental Health Products Inc · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
Pomee — POMEE CORPORATION · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: PDT, Inc.

Sources (2)

FDA UDI 6fffb3f5-52c3-42b2-8765-05d9b2ca1465 34 fields · synced Jul 19, 2026
EUDAMED 7171c8ef-b939-4c7e-bcb3-a66c581b2efc 61 fields · synced Jul 19, 2026