DIO UF HSA Internal SUB-Merged Implant System

The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged…

Registry build 21.09.26

The DIO UF HSA Internal Sub-Merged Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surery. A successfully osseointegrated implant willl achieve a firm implant when the fixture is operated under controlled conditions, per well known clinical studies. There are intended for use in partially or fully edendulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist of screws(Cover Screw, Coping Screw), abutments(Screw retained type, Cemented retained type, Over denture retained type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F67) and Ti-6A1-4VELI(ASTM F136) intended to be used in a narrow tooth gap after implant insertion. And the screw is used to protect exposed top of the implant or to attach the abutment to implant.

70manufacturers in China registered for this device type
27catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NDP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66

Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous

Record

Regulatory record for DIO UF HSA Internal SUB-Merged Implant System
Listed by DIO Corporation, South Korea
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Repacker / relabeller, Manufacturer, Exporter
Record published 2022-03-01
Record revised 2022-11-21 (version 3)

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
Storage Storage environment temperature 1 to 30 °C
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DIO UF HSA Internal SUB-Merged Implant System
Catalogue number Size Status
SSAA 6507 Ø6.5X7.0mm In distribution
SSAP 6510S Ø6.5X10.0mm Single In distribution
API 60714 Ø6.3X10.0mm Octa In distribution
SSAP 6510B Ø6.5X10.0mm Bridge In distribution
SSAA 7507 Ø7.5X7.0mm In distribution
SSAA 7504 Ø7.5X4.0mm In distribution
SSAA 5504 Ø5.5X4.0mm In distribution
IOTI 65010 Ø6.6X10.0mm Octa In distribution
SSAP 5510B Ø5.5X10.0mm Bridge In distribution
IOTI 48010 Ø5.5X10.0mm Octa In distribution
SSAA 4504 Ø4.5X4.0mm In distribution
SSAA 5505 Ø5.5X5.5mm In distribution
SSAA 6504 Ø6.5X4.0mm In distribution
SSAP 7510S Ø7.5X10.0mm Single In distribution
SSAP 4510B Ø4.5X10.0mm Bridge In distribution
SSAP 4510S Ø4.5X10.0mm Single In distribution
SSAA 4505 Ø4.5X5.5mm In distribution
SSAA 4507 Ø4.5X7.0mm In distribution
RCI 60014 Ø6.0X10.0mm In distribution
SSAA 6505 Ø6.5X5.5mm In distribution
IPI 60710N Ø6.4X10.0mm Non-Octa In distribution
SSAP 5510S Ø5.5X10.0mm Single In distribution
SSFA 4012 Ø4.0X12.0mm In distribution
SSAA 7505 Ø7.5X5.5mm In distribution
SSAP 7510B Ø7.5X10.0mm Bridge In distribution
SSAA 5507 Ø5.5X7.0mm In distribution
IOTI 60010 Ø6.1X10.0mm Octa In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Accessories, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,379
Accessories, Implant, Dental, Endosseous Institut Straumann AG 1,320
Neobiotech Implant System Neobiotech Co., Ltd. 1,112
Inclusive Prismatik Dentalcraft, Inc. 1,045
Medentika Medentika GmbH 1,042
BioHorizons Biohorizons Implant Systems Inc. 1,008
IPD Implant Protesis Dental 2004 SL 998
Klockner Soadco, S.L. 995
Dynamic Abutment Solutions Talladium España, SL 877
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 738
Nobel Biocare® Nobel Biocare AB 703
MIS MIS Implants Technologies Ltd. 615

Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous

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