# K130534: Diplomat

- Pathway: 510(k) (Traditional)
- Applicant: Diplomat Dental S.R.O.
- Decided: Oct 30, 2013 after 243 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962071 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032543: Sirona Dental Systems C8+Dental Operative Unit with Accessories, Sirona Dental Systems GmbH (2003) Summary page 3.

## Indications for use
Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are Intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist If permitted by applicable law.

Source page: https://510kreport.com/device/K130534
Methodology: https://510kreport.com/methodology