Restore

9 catalogue numbers from L9105-1K, listed by Keystone Dental Inc., United States, under Dental Implant Surgical Tray. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

All of them in Hebei.

Chinese manufacturers registered for FDA product code OFY
Manufacturer City Province Registered as Device types
Cangzhou Lankang Medical Instruments Developing Co., Ltd. Cangzhou Hebei Manufacturer 40
Huanghua DK Dental Co., Ltd. Huanghua Hebei Manufacturer 37

Record

Regulatory record for Restore
Listed by Keystone Dental Inc., United States
FDA product code OFY
Device type Dental Implant Surgical Tray
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Complaint-file establishment, Manufacturer, Exporter
Record published 2019-05-24
Record revised 2021-03-25 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Restore
Catalogue number Size Status
L9105-1K In distribution
L9102-1K In distribution
L9104-1K In distribution
L1804-01K In distribution
L9106-1K In distribution
L9108-1K In distribution
11026K In distribution
11028K In distribution
L9102-1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Intra-Lock Intra-Lock International 31
Ditron Dental Ditron Dental Ltd 10
Prima Keystone Dental Inc. 9
Stage-1 Keystone Dental Inc. 7
DIO Master Kit DIO Corporation 6
Genesis Keystone Dental Inc. 5
TRI TRI Dental Implants INT. AG 5
FTN Surgical Kit DIO Corporation 5
Stradis Stradis Healthcare 5
UF(II) Starter Kit DIO Corporation 4
RS-Standard Internal Hex Plastic Surgical Kit-Advanced Short Drills Adin Dental Implant Systems Ltd. 3
RS-Standard Internal Hex Plastic Surgical Kit-Starter Adin Dental Implant Systems Ltd. 3

Showing 12 of 110. All products under Dental Implant Surgical Tray

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