Data / Medical devices / United States / Evolve Dental Technologies, Inc.
Evolve Dental Technologies, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Evolve Dental Technologies, Inc. is registered with the FDA (registration 3010407924) in Irvine, CA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 14, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010407924
- Address
- 5 Vanderbilt, Irvine, CA, United States, 92618
- Owner or operator
- Evolve Dental Technologies, Inc. (10044828)
- Roles
- Repackager or relabeler
- First device listed
- August 2, 2013
- Registered through
- 2026
- Brand names listed
- KoR Cheek Retractor, KoR Light Body Wash, KoR Putty Fast Set, KoR Putty Regular Set, KöR Dam, KöR Disposable Impression Trays, KöR EVA Sheets, KöR Oral Suction Tip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| May 14, 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| December 22, 1998 | K983477 | SUPER SEAL | EJK | Substantially Equivalent | Phoenix Dental, Inc. | accessdata.fda.gov |
| June 7, 1982 | K821221 | DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Liner, Cavity, Calcium Hydroxide
- All makers of Mouthpiece, Saliva Ejector
- All makers of Retractor, All Types
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Accessories, Retractor, Dental
- All makers of Material, Impression
Updated May 14, 2004. 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.