ENCORE LABORATORY

FDA Device Registration & Listing · Santa Ana, CA, US · Registration 3020749939

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
3020749939
FEI Number
3020749939
Entity Name
ENCORE LABORATORY
City/State/Country
Santa Ana, CA, US
Establishment Address
1520 BROOKHOLLOW DR, STE 38, Santa Ana, CA 92705, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
enCore Laboratory (Owner Number: 10083076)
Owner / Operator Contact Address
1520 BROOKHOLLOW DR, STE 38, Santa Ana, CA 92705, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K241369
PMA Number
N/A

All Registered Proprietary Names

enCore Impression Material

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter Dental Class 2 872.3660 2026-03-23
OBR Mouthguard, Over-The-Counter Unknown Class U N/A 2026-01-06
ELW Material, Impression Dental Class 2 872.3660 2025-12-31
MQC Mouthguard, Prescription Unknown Class U N/A 2024-10-23

Official Correspondent

Ben Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

enCore Laboratory
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
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

Similar Registrations

Registration Number Establishment Name Location
3017575849 GRINDGUARD INC San Francisco, CA, US
3030268763 OWL DENTAL San Leandro, CA, US
3029913483 DIMEDI KOREA INC Busan, KR
1719513 MEDTECH PRODUCTS, INC. Tarrytown, NY, US
3015525101 MIDWEST TEK New Albany, IN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020749939. Last updated year: 2026. Please use registration number 3020749939 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.