Registered with FDA
CBR Enterprise Limited
Hong Kong, Hong Kong SAR China. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Hong Kong SAR China
Devices listed with FDA
What CBR Enterprise 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 |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | — | 2019 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | — | 2019 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | — | 2025 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | DRILL, DENTAL, INTRAORAL | 2021 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | INSTRUMENTS, DENTAL HAND | 2021 |
| Articulation PaperEFH · Class 1 | — | Lister | — | 2017 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | — | 2019 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | — | 2024 |
| Amalgam AlloyEJJ · Class 2 | — | Lister | — | 2024 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | POST, ROOT CANAL | 2021 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | — | 2017 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
CBR Enterprise Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Procter & Gamble (5), Southern Dental Industries, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Aug 2020 | K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | Procter & Gamble | JEQ Powered Toothbrush |
| 15 Sep 2014 | K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | Procter & Gamble | JEQ Powered Toothbrush |
| 5 Jun 2006 | K061351 | ORAL-B SONIC COMPLETE | Procter & Gamble | JEQ Powered Toothbrush |
| 31 May 2006 | K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | Procter & Gamble | JEQ Powered Toothbrush |
| 28 Jan 1993 | K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Procter & Gamble | JES Dental Floss |
| 27 Aug 1980 | K801639 | PERMITE DENTAL AMALGAM ALLOY | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CBR ENTERPRISE LIMITEDFDA reg. 3013557562 | Hong Kong, Hong Kong SAR China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054430). 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.