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PDT, Inc.

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref R144Model Curettes and Scalers

by PDT, Inc.

Identity

Trade Name
Queen of Hearts™ EUDAMED
PDT, Inc. FDA UDI
Generic Name
Periodontal curette FDA UDI
Device Name
Hygiene instruments EUDAMED
Queen of Hearts FDA UDI
Model / Reference
Curettes and Scalers EUDAMED
R144 EUDAMED
R144 Queen of Hearts FDA UDI
Description
Queen of Hearts FDA UDI

Identifiers

Catalog Number
R144 FDA UDI
Primary DI / UDI-DI
00813677020987 EUDAMEDFDA UDI
Basic UDI-DI
0813677021801WC EUDAMED
Direct Marketing DI
00813677020987 EUDAMED
FDA Product Code
EMS FDA UDI
EMDN Code
Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Periodontal curette FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.4565 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Periodontal curette

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

Similar devices

Also classified as Periodontal curette.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PDT, Inc.

Sources (2)

  • FDA UDI 08b7dce0-2294-45c6-ba26-b159876ced1d 34 fields · synced Jul 12, 2026
  • EUDAMED 4b59db21-cdfb-4ab5-a5ee-e4c11916b1f9 61 fields · synced Jul 12, 2026