What is FDA product code NHA?

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Procera® · Abutment, Implant, Dental, Endosseous → Dental

Name: Procera®
Brand: Procera®

15manufacturers in China registered for this device type

148catalogue numbers in this listing

43510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NHA
Manufacturer	City	Province	Registered as	Device types
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Modern Dental Laboratory (DG) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	15
Exceldent Dental Technology Development Co., Ltd.	Zhuhai	Guangdong	Contract manufacturer	12
DTS Digital Dental LAB	Shenzhen	Guangdong	Contract manufacturer	11
KTJ Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	11
Shimmer Computerized Dental Technology Co., Ltd.	Zhuhai	Guangdong	Contract manufacturer	10
Zhuhai Crystal Dental Technology Co., Ltd.	Zhuhai	Guangdong	Contract manufacturer	9
NEW Perfect Dental LAB	Shenzhen	Guangdong	Contract manufacturer	8
Shenzhen Jiahong Dental Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	7
Jiangsu Trausim Medical Instrument Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	3
Chengdu Besmile Medical Technology Co., Ltd.	Chengdu	Sichuan	Manufacturer	14
CBD Dental LAB, Inc	Shenzhen	Guangdong	Manufacturer	11

Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous

Record

Regulatory record for Procera®
Listed by	Nobel Biocare AB, Sweden
FDA product code	NHA
Device type	Abutment, Implant, Dental, Endosseous
Device class	Class 2
Regulation	21 CFR 872.3630
Establishment	Specification developer, Manufacturer
Record published	2015-09-17
Record revised	2024-06-05 (version 10)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date, serial number
Distribution end date	2024-05-24
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Procera®
Catalogue number	Size	Status
31984		In distribution
10-4010		Withdrawn
10-6008-10		Withdrawn
10-4026		Withdrawn
10-6008-5		Withdrawn
10-4061		Withdrawn
10-6062-10		Withdrawn
10-6002		Withdrawn
10-6041		Withdrawn
10-6004		Withdrawn
10-4055		Withdrawn
10-6005		Withdrawn
10-6007-5		Withdrawn
10-5026		Withdrawn
10-6004-10		Withdrawn
10-6025		Withdrawn
10-6062-15		Withdrawn
10-6027-10		Withdrawn
10-5004		Withdrawn
10-6025-15		Withdrawn
33549		Withdrawn
10-4002		Withdrawn
33564		Withdrawn
10-6006-5		Withdrawn
10-4006		Withdrawn
33548		Withdrawn
10-6061		Withdrawn
10-4056		Withdrawn
10-6009-10		Withdrawn
10-4022		Withdrawn
10-6063-5		Withdrawn
26066X		Withdrawn
10-6005-15		Withdrawn
10-6061-10		Withdrawn
10-4025		Withdrawn
26070X		Withdrawn
10-4048		Withdrawn
10-6065-15		Withdrawn
10-4053		Withdrawn
10-6064-5		Withdrawn
10-6062		Withdrawn
10-6002-5		Withdrawn
10-6059-5		Withdrawn
10-6064-15		Withdrawn
10-6063-15		Withdrawn
10-5008		Withdrawn
33562		Withdrawn
10-6058-5		Withdrawn
30-1001		Withdrawn
10-6008		Withdrawn
10-4001		Withdrawn
33561		Withdrawn
10-6003-5		Withdrawn
10-6028-10		Withdrawn
10-4044		Withdrawn
10-6006-10		Withdrawn
10-6063-10		Withdrawn
10-6059-15		Withdrawn
10-6005-5		Withdrawn
10-6027-15		Withdrawn
10-6010-10		Withdrawn
10-4021		Withdrawn
10-6010-15		Withdrawn
10-6003-15		Withdrawn
10-6026-15		Withdrawn
10-6005-10		Withdrawn
10-6009-15		Withdrawn
10-6065		Withdrawn
10-6007		Withdrawn
10-6028-5		Withdrawn
10-6001-5		Withdrawn
15-1003		Withdrawn
10-6063		Withdrawn
10-6065-10		Withdrawn
10-6027		Withdrawn
10-6009-5		Withdrawn
10-6025-10		Withdrawn
10-4049		Withdrawn
10-6060		Withdrawn
10-6010-5		Withdrawn
18376		Withdrawn
10-6064-10		Withdrawn
10-6004-15		Withdrawn
26071X		Withdrawn
10-6044		Withdrawn
10-6009		Withdrawn
10-4009		Withdrawn
10-5001		Withdrawn
10-6006-15		Withdrawn
26069X		Withdrawn
10-4023		Withdrawn
10-4024		Withdrawn
10-4051		Withdrawn
10-6065-5		Withdrawn
10-6003		Withdrawn
30-1003		Withdrawn
10-4027		Withdrawn
10-4028		Withdrawn
10-6058-15		Withdrawn
10-4057		Withdrawn
10-6064		Withdrawn
10-6059		Withdrawn
10-6001-15		Withdrawn
26067X		Withdrawn
30-1002		Withdrawn
10-6002-15		Withdrawn
10-4003		Withdrawn
10-6001		Withdrawn
10-6003-10		Withdrawn
10-6007-15		Withdrawn
33753		Withdrawn
33563		Withdrawn
10-6026-5		Withdrawn
26068X		Withdrawn
10-4004		Withdrawn
15-1051		Withdrawn
10-6061-15		Withdrawn
10-6028-15		Withdrawn
10-6028		Withdrawn
10-6061-5		Withdrawn
10-4046		Withdrawn
10-6025-5		Withdrawn
10-6004-5		Withdrawn
10-4047		Withdrawn
10-6060-5		Withdrawn
10-6026		Withdrawn
10-6058-10		Withdrawn
10-6026-10		Withdrawn
10-6059-10		Withdrawn
10-4050		Withdrawn
10-6007-10		Withdrawn
10-6010		Withdrawn
33616		Withdrawn
10-6008-15		Withdrawn
10-4005		Withdrawn
10-6027-5		Withdrawn
10-6001-10		Withdrawn
10-6002-10		Withdrawn
10-6058		Withdrawn
31780		Withdrawn
18377		Withdrawn
10-6060-15		Withdrawn
10-6062-5		Withdrawn
10-4041		Withdrawn
10-4007		Withdrawn
10-6060-10		Withdrawn
10-4008		Withdrawn
10-6006		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MEDENTiKA	Medentika GmbH	2,553
LW Vis Abutment	Ossvis Co., Ltd.	2,520
Dess dental smart solutions	Terrats Medical SL	1,715
Locator	Zest Anchors, LLC	1,643
NobelProcera®	Nobel Biocare AB	1,526
Azure	Terrats Medical SL	1,360
Neodent	Jjgc Indústria e Comércio de Materiais Dentários S.A.	1,308
LW Vis Abutment SET	Ossvis Co., Ltd.	1,260
Abutment, Implant, Dental, Endosseous	Southern Implants (PTY) Ltd	1,240
Healing Abutment	Megagen Implant Co., Ltd.	1,218
Chaorum Implant System	Medimecca Co Ltd	1,084
OT Equator	Rhein 83 SRL	1,051

Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K253999	2026-08-06
K240346	2025-01-03
K233208	2024-01-24
K223677	2023-04-28
K202452	2020-12-03
K200040	2020-03-30
K181869	2018-12-12
K180899	2018-10-31
K172854	2017-12-14
K171466	2017-11-29
K171142	2017-10-26
K161416	2017-03-16
K161655	2017-02-28
K161435	2016-11-22
K160158	2016-07-25
K153036	2016-06-02
K133377	2014-04-04
K120954	2013-06-05
K122602	2013-03-13
K112259	2011-10-28
K111581	2011-06-23
K101714	2010-08-31
K093643	2010-06-24
K091848	2009-10-16
K091907	2009-10-06
K091904	2009-09-25
K091756	2009-09-22
K090069	2009-05-07
K072129	2008-02-22
K072570	2007-12-28
K063592	2007-02-27
K062749	2006-11-29
K061529	2006-08-23
K061478	2006-08-21
K061477	2006-08-11
K053050	2006-02-22
K053068	2006-02-22
K053125	2006-02-22
K053602	2006-02-10
K053091	2006-01-27
K043042	2004-11-18
K041236	2004-05-26
K031719	2003-07-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Procera®