# PDT, Inc. R934 PDT Composite & Crown Prep Kit

> Listed: FDA GUDID listing, no authorization on record. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/pdt-inc-r934>
- Manufacturer: [PDT, Inc.](https://devicerts.com/manufacturers/pdt-inc) (United States)
- Device class: Class I (US FDA)
- FDA product code: EKC, EAX, FSM, EKB, EJB, EKH, DZN, EJY, EIC, EGN
- GMDN: Dental spatula, reusable (38530)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00813677024954 · listed 2024-06-26 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: PDT, Inc. [FDA GUDID (AccessGUDID)]
- Generic name: Dental spatula, reusable [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: R934 PDT Composite & Crown Prep Kit [FDA GUDID (AccessGUDID)]; R934 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00813677024954 [FDA GUDID (AccessGUDID)]
- FDA product code: EKC [FDA GUDID (AccessGUDID)]; EAX [FDA GUDID (AccessGUDID)]; FSM [FDA GUDID (AccessGUDID)]; EKB [FDA GUDID (AccessGUDID)]; EJB [FDA GUDID (AccessGUDID)]; EKH [FDA GUDID (AccessGUDID)]; DZN [FDA GUDID (AccessGUDID)]; EJY [FDA GUDID (AccessGUDID)]; EIC [FDA GUDID (AccessGUDID)]; EGN [FDA GUDID (AccessGUDID)]
- GMDN term: Dental spatula, reusable (38530) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 872.4565 [FDA GUDID (AccessGUDID)]; 878.4800 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: PDT, Inc. R934 PDT Composite & Crown Prep Kit, PDT, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/pdt-inc-r934 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/pdt-inc-r934.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/pdt-inc-r934
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.