Manufacturer registered with FDA
Bethel Co., Ltd.
Ishioka, Japan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Japan
Devices listed with FDA
What Bethel 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 |
|---|---|---|---|---|
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Irri-Tip 25 double side ventIrri-Tip 27 double side ventIrri-Tip 30 double side ventSeptodont Precision TipsTip 21G BentTip 21G Bent75Tip 21G Long BentTip 21G Long StraightTip 21G StraightTip 22G Curve 6 moreTip 25G BentTip 25G Long BentTip 25G Long StraightTip 25G StraightTip 27G BentTip 27G Straight | 2024 |
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 |
|---|---|---|
| BETHEL CO., LTD.FDA reg. 3015142372 | Ishioka Ibaraki, Japan | Contract manufacturer, Foreign exporter, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092179). 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.