Dentech Corp.
Tokyo, JP
DENTECH CORP. appears in FDA device records in Tokyo, JP. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Dentech Corp. between 1990 and 1995. The busiest year on record is 1990, with 1. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1995 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611450 | 3002809535 | DENTECH CORP. | 53 SHIMIZU-CHO, ITABASHI-KU, TOKYO 174-0053 JP | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EIFAccessories, Retractor, Dental
- LYSBone Mill
- EJLBur, Dental
- KLCChair, Dental, With Operative Unit
- EEFClamp, Rubber Dam
- EIEDam, Rubber
- DZADrill, Dental, Intraoral
- EFKForceps, Articulation Paper
- EFLForceps, Dressing, Dental
- EMHForceps, Rongeur, Surgical
- EJGForceps, Rubber Dam Clamp
- EJEFrame, Rubber Dam
- EILGauge, Depth, Instrument, Dental
- EKFInstrument, Contouring, Matrix, Operative
- ELAInstrument, Hand, Calculus Removal
- DZNInstruments, Dental Hand
- EMOKnife, Periodontic
- EAYLight, Fiber Optic, Dental
- EAXMirror, Mouth
- DYNMouthpiece, Saliva Ejector
- JEPRetainer, Matrix
- FTYTape, Measuring, Rulers And Calipers
- EHYTray, Impression, Preformed
- EIAUnit, Operative Dental
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1676-2021 | Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment. | Removing parts for safety reasons due to possible breakage. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain