The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for High Speed Air Turbine Handpieces, Par-4hex/4hx Series (twin Power Turbine 4h).
| Device ID | K061701 |
| 510k Number | K061701 |
| Device Name: | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-16 |
| Decision Date | 2006-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213745241 | K061701 | 000 |
| 04548213060160 | K061701 | 000 |
| 04548213060177 | K061701 | 000 |
| 04548213057320 | K061701 | 000 |
| 04548213057337 | K061701 | 000 |
| 04548213057344 | K061701 | 000 |
| 04548213057368 | K061701 | 000 |
| 04548213057375 | K061701 | 000 |
| 04548213745043 | K061701 | 000 |
| 04548213060153 | K061701 | 000 |