Data / Medical devices / United States / Enamel Pure Inc.
Enamel Pure Inc.: FDA-registered device maker in Worcester, MA, United States, 1 510(k) clearance
Enamel Pure Inc. is registered with the FDA (registration 3032916575) in Worcester, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3032916575
- Address
- 17 Briden St, Worcester, MA, United States, 01605
- Owner or operator
- Enamel Pure (10091424)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 3, 2024
- Registered through
- 2026
- Brand names listed
- LUNE PureHygiene
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2024 | K234085 | LUNE PureHygiene | GEX | Substantially Equivalent | Enamel Pure | accessdata.fda.gov |
Compare with other makers
Updated March 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.