NobelZygoma™ TiUltra™

NobelZygoma™ 45° Implant Bone Mill with Guide

Registry build 21.09.26
70manufacturers in China registered for this device type
16catalogue 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 NobelZygoma™ TiUltra™
Listed by Nobel Biocare AB, Sweden
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2025-10-13

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Keep away from sunlight. Keep dry
Sizes Outer diameter 2.9 to 3.5 mm; angle 45 °

Catalogue Numbers

Catalogue numbers for NobelZygoma™ TiUltra™
Catalogue number Size Status
301659 Angle 45.000 ° In distribution
301656 In distribution
301602 Outer Diameter 2.900 mm In distribution
301605 Outer Diameter 3.500 mm In distribution
301601 In distribution
301607 Outer Diameter 3.500 mm In distribution
301583 In distribution
301660 In distribution
301603 Outer Diameter 2.900 mm In distribution
301604 Outer Diameter 3.500 mm In distribution
301658 In distribution
301606 Outer Diameter 3.500 mm In distribution
301584 Outer Diameter 3.500 mm In distribution
301657 In distribution
301582 In distribution
301585 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