PDT, Inc. R270 4/5 DC

PDT, Inc. R270 4/5 DC is a dental restoration carver (FDA Class I; FDA product code EKH, Carver, Dental Amalgam, Operative) made by PDT, Inc., listed in FDA GUDID since 30 Apr 2021 (UDI-DI 00813677021489), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00813677021489 UDI-DI	Date30 Apr 2021Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00813677021489

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: PDT, Inc.
Generic name: Dental restoration carver, amalgam, reusable
Model / Ref / Catalog: R270 4/5 DC, R270

Primary DI / UDI-DI: 00813677021489
FDA product code: EKH
GMDN term: Dental restoration carver, amalgam, reusable

Device class: Class I
Regulation number: 872.4565
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code EKH (Carver, Dental Amalgam, Operative).

Other devices from PDT, Inc.

PDT, Inc.

Class I
PDT, Inc. H5-N128

Class I
Montana Black 23

Class I
Boge Precision Duo

Class I

See all devices from PDT, Inc. →

Properties

Sterilise before use
Premarket exempt

Other properties (13, all answered No)