FDA Registration Active 🇺🇸 United States

EVOLVE DENTAL TECHNOLOGIES, INC.

Reg #: 3010407924 · FEI: 3010407924 · Expires 2026
Products
7
Proprietary Names
9
Establishment Types
1
Classifications
7

Registration Details

Registration Name
EVOLVE DENTAL TECHNOLOGIES, INC.
Registration Number
3010407924
FEI Number
3010407924
Status
Active
Expiry Year
2026
Initial Importer
No
Address
5 Vanderbilt
City
Irvine
State
CA
ZIP
92618
Country
US

Regulatory Submissions

510(k) Number
K983477

Owner / Operator

Firm Name
Evolve Dental Technologies, Inc.
Operator Number
10044828
Address
5 Vanderbilt
City
Irvine
State
CA
Postal Code
92618
Country
US
Correspondent
Crystal Lopez

Products

Device Name Product Code
Material, Impression Tray, Resin EBH
Applicator, Absorbent Tipped, Non-Sterile KXF
Liner, Cavity, Calcium Hydroxide EJK
Material, Impression ELW
Mouthpiece, Saliva Ejector DYN
Retractor, All Types EIG
Accessories, Retractor, Dental EIF

Proprietary Names

KöR Disposable Impression Trays KöR EVA Sheets KöR Teeth Desensitizer Swabs KoR Putty Regular Set KoR Putty Fast Set KöR Oral Suction Tip KoR Light Body Wash KöR Dam KoR Cheek Retractor

Establishment Types

Repack or Relabel Medical Device