HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)

Handpiece, Belt And/or Gear Driven, Dental

J. MORITA USA, INC.

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).

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548213745241	K061701	000
04548213745043	K061701	000