Manufacturer registered with FDA
Dongguan Integrity Medical Instrument Co.,Ltd.
Dongguan, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Dongguan Integrity Medical Instrument Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Blue Diamond Bur; Carbide Bur; Stainless Bur | 2025 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Point, Model: for Protaper with LengthMarkGutta Percha Point, Model: Taper02, 04/06, for Protaper,Taper 02 with LengthMark,Taper 04/0/06 with LengthMark | 2025 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points, Model: Taper 02, Taper 04/0/06, for Protaper, Taper 02 with LengthMarkAbsorbent Paper Points, Model:Taper 04/06 with LengthMark, for Protaper with LengthMark | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Endodontic instruments (Gate drills, Peeso reamers)Endodontic Root Canal Files: NiTi dental root canal files (K-files, H-files, Reamers, Spreaders, Pluggers)Engine endodontic files(Retreatment files,PT-files,PT-files blue,PT-files gold,PT-next, Only one gold, V-silver, V-blueHand use files (PT-files hand use, PT-files blue hand use)Paste carriersStainless steel dental root canal files(K-files, H-files, Reamers, Spreaders, Pluggers, C+ files, U-files) | 2021 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | Barbed Broach (Nerve Broach) Length: 21mm/25mm Model: 0#,1#, 2#, 3#, 4#, 5#, 6#, 0-6# | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DONGGUAN INTEGRITY MEDICAL INSTRUMENT CO.,LTD.FDA reg. 3021284315 | Dongguan Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083415). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.