Manufacturer registered with FDA
Pacific Care Limited
N.T., Hong Kong SAR China. Lists 14 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 14
- Brands and models
- 11
- 510(k) clearances
- 12025–2025
- Markets registered in
- 1United States
- Establishments
- 1Hong Kong SAR China
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Pacific Care Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Practicon / IndiGreen Innovations | 2012 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2010 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Bluewater Dental Innovations / Shark Tray | 2004 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Astek Innovations Ltd. / Medicom | 2012 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Sunstar Butler, Inc. | 2010 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Disposable Prophy Angle | 2025 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Sunstar Butler, Inc. | 2010 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | — | 2016 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | IMPRESSION SYRINGE | 2004 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | PREMIUM SCALER, SONIC SCALER | 2008 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Astek Innovations Ltd. / Medicom | 2012 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | — | 2015 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | United Exchange Corp | 2016 |
| Tongue ScraperLCN · Class 1 | — | Maker | Pearson Dental Supply, Inc | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Pacific Care Limited as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 May 2025 | K240950 | Disposable Prophy Angle | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Some of these clearances are listed with FDA today by another company: AMD Medicom Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PACIFIC CARE LIMITED / PACIFICARE ASIA LIMITEDFDA reg. 3004605493 | Hong Kong, Hong Kong SAR China | Contract manufacturer, Manufacturer |
Other names on FDA records
Pacific Care Limited / Pacificare Asia Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9064332). 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.