Octa Abutment

AnyOne Internal Ø5.8/ C=1.5

Registry build 21.09.26
15manufacturers in China registered for this device type
49catalogue numbers in this listing
7510(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 Octa Abutment
Listed by Megagen Implant Co., Ltd., South Korea
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Repacker / relabeller, Manufacturer, Exporter
510(k) K242030
Record published 2025-02-28
Record revised 2026-06-19 (version 6)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Octa Abutment
Catalogue number Size Status
AANOAF4030 In distribution
OA6015 In distribution
IOA200 In distribution
AANOAF6030 In distribution
OA5015 In distribution
AANOAF4010 In distribution
OA5035 In distribution
AROOAR6050 In distribution
AROOAR5010 In distribution
OA6025 In distribution
OA5010 In distribution
AROOAN4030 In distribution
OA6045 In distribution
AANOAF6040 In distribution
AROOAR5050 In distribution
AROOAR5030 In distribution
OA4010 In distribution
OA4025 In distribution
OA5055 In distribution
AANOAF4020 In distribution
AANOAF6050 In distribution
AANOAF4040 In distribution
AANOAF0020 In distribution
AANOAF0040 In distribution
OA4015 In distribution
AROOAR5040 In distribution
OA4035 In distribution
OA6010 In distribution
AANOAF0030 In distribution
AANOAF0010 In distribution
AANOAF0050 In distribution
OA6055 In distribution
AANOAF6010 In distribution
AANOAF4050 In distribution
AROOAR6020 In distribution
OA4045 In distribution
AROOAN4020 In distribution
AROOAN4010 In distribution
OA4055 In distribution
OA6035 In distribution
AROOAR6010 In distribution
OA5045 In distribution
AROOAR6030 In distribution
AANOAF6020 In distribution
OA5025 In distribution
AROOAR6040 In distribution
AROOAN4050 In distribution
AROOAN4040 In distribution
AROOAR5020 In distribution

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
K242030 2025-01-13
K234142 2024-09-18
K233450 2024-01-22
K220562 2022-11-10
K210826 2022-02-03
K203808 2021-10-20
K192614 2020-02-13

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer