Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013012934

FEI Number

3013012934

Entity Name

DENTKIST, INC.

City/State/Country

Gunpo-si Gyeonggi, KR

Establishment Address

(Dangjeong-dong) 3, Nongshim-ro, Gunpo-si Gyeonggi 15842, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dentkist, Inc. (Owner Number: 10052020)

Owner / Operator Contact Address

(Dangjeong-dong) 3, Nongshim-ro, Gunpo-si, KR-41 15842, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CharmFlex®Putty CharmFlex®Putty Green CharmFlex®Bite Clear CharmFlex®Bite Fast CharmFlex®Denture CharmFlex®Bite CharmFlex®Heavy tube type CharmFlex®Putty Soft CharmFlex®Light LV CharmFlex®Light XLV CharmFlex®Light Premium CharmFlex®Heavy cartridge type CharmFlex®Regular CharmFil Plus CharmFil Plus Caps CharmFil Flow Flow Resin ALOOZ

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2016-06-01
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-12-21

Official Correspondent

Shin Heang Lee

US Agent Details

Peter Chung Email: peterchung210@gmail.com Phone: (412) 5128802

Related Public Records

Same Entity

Dentkist, 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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3030268763	OWL DENTAL	San Leandro, CA, US
8021038	VANNINI DENTAL INDUSTRY SRL	GRASSINA(FI) Firenze, IT
2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005558160	MAXILL, INC.	ST. THOMAS Ontario, CA
9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013012934. Last updated year: 2026. Please use registration number 3013012934 when referencing this establishment in official correspondence.