Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005952241

FEI Number

3005952241

Entity Name

ACER DENTALLAB CO LIMITED

City/State/Country

HONGKONG, HK

Establishment Address

FLAT/RM903 9/F HART AVENUE PLAZA 5-9 HART AVENUE, TRIM SHA TSUI KL, HONGKONG 00000, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ACER DENTALLAB CO LIMITED (Owner Number: 10045567)

Owner / Operator Contact Address

FLAT/RM903 9/F HART AVENUE PLAZA 5-9 HAR, TRIM SHA TSUI KL, HONGKONG, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212577

PMA Number

N/A

All Registered Proprietary Names

Restoration, porcelain acer Dess Implant Dess Implant Dentures, full acer Dess Implant acer Dess Implant Dess Implant acer Dess Implant Dess Implant acer Dess Implant Dess Implant Dess Implant Dess Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2013-12-02
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2017-06-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NSL	Dentures, Full	Unknown	Class N	N/A	2013-12-02
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2017-06-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2017-06-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2017-06-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2017-06-20
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-13

Official Correspondent

Long Cai

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

ACER DENTALLAB CO LIMITED

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

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.

Similar Registrations

Registration Number	Establishment Name	Location
3021389380	ABL DENTAL SOLUTIONS S.A.S	Envigado Antioquia, CO
3005310881	DIGITAL DENTAL FUSION KOREA	Seoul, KR
3021241833	LEAGUE DENTAL TECHNOLOGY LTD	Shenzhen Guangdong, CN
3007268434	ADS DENTAL LAB LTD.	Shenzhen Guangdong, CN
3045005836	EDENTAL LAB CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005952241. Last updated year: 2026. Please use registration number 3005952241 when referencing this establishment in official correspondence.