EVOLVE DENTAL TECHNOLOGIES, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3010407924

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010407924
FEI Number
3010407924
Entity Name
EVOLVE DENTAL TECHNOLOGIES, INC.
City/State/Country
Irvine, CA, US
Establishment Address
5 Vanderbilt, Irvine, CA 92618, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Evolve Dental Technologies, Inc. (Owner Number: 10044828)
Owner / Operator Contact Address
5 Vanderbilt, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2013-08-02
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2013-08-02
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2016-09-06
ELW Material, Impression Dental Class 2 872.3660 2017-03-09
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2013-08-02
ELW Material, Impression Dental Class 2 872.3660 2013-08-02
EIG Retractor, All Types Dental Class 1 872.4565 2013-08-02

Official Correspondent

Crystal Lopez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Evolve Dental Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K941532 Bio-Probe, Inc. BIOCALEX 6/9 1994-08-02
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04

Similar Registrations

Registration Number Establishment Name Location
3010622180 MEGA-PHYSIK Ges. fuer physikalische Messtechnik mbh Co KG Rastatt Baden-Wurttemberg, DE
3009509745 DENT A PHARM PRODUKTIONSGESELLSCHAFT MBH Barmstedt Schleswig-Holstein, DE
2411056 BUFFALO DENTAL MFG. CO., INC. SYOSSET, NY, US
1417846 FRICKE DENTAL MFG. CO. Streamwood, IL, US
3016447764 DSI DENTAL SOLUTIONS LTD Ashdod Southern, IL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010407924. Last updated year: 2026. Please use registration number 3010407924 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.