FDA 510(k) clearance · back to tracker

Firstar Dental Unit

Firstar Dental Company cleared K231297 on 2025-01-27, decision: substantially equivalent

K-number

K231297

Sponsor

Firstar Dental Company

Device

Firstar Dental Unit

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-01-27

Product code

EIA

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.6640

Official FDA record

Open K231297on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K231297 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.