Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004748290

FEI Number

3004748290

Entity Name

HEXA CERAM CO., LTD.

City/State/Country

Sansai Chiang Mai, TH

Establishment Address

213 Moo 5 Sanpraned Sansai Chiangmai Thailand 50210, Sansai Chiang Mai 50210, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HEXA CERAM CO., LTD. (Owner Number: 10092580)

Owner / Operator Contact Address

213 Moo 5 Sanpraned Sansai Chiangmai Thailand 50210, Sansai, TH-50 50210, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN; NNC Variobase Abutment, with screw, D 55mm, H 4mm Orthodontic Appliance; Screw Appliance; splint EMAX Crown / Bridge; Full Zircon restoration; Full Ceramic Restoration; Porcelain Restoration; Zirconia Crown / Bridge PFM Porcelain Fused to Metal Respire Blue Series RPE Rapid Palatal Expander ACRYLIC DENTURE; FULL DENTURE; IMMEDIATE DENTURE Customized Abutment Respire Pink Series - Herbst

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-05-19
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2025-05-07
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2025-01-26
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2025-01-26
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-05-01
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2025-09-15
NSL	Dentures, Full	Unknown	Class N	N/A	2025-01-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-05-07
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2025-05-01

Official Correspondent

Apichai Meekiatichaikun

US Agent Details

Ivan Siu Business: MicroDental California Email: Isiu@Microdental.com Phone: (925) 4356188

Related Public Records

Same Entity

HEXA CERAM CO., LTD.

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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004748290. Last updated year: 2026. Please use registration number 3004748290 when referencing this establishment in official correspondence.