DELIGHT

Light, Operating, Dental

PLANMECA USA, INC.

The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Delight.

Pre-market Notification Details

• Device ID: K923462
• 510k Number: K923462
• Device Name: DELIGHT
• Classification: Light, Operating, Dental
• Applicant: PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI
• Contact: Ismo Seppa
• Correspondent: Ismo Seppa; PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI
• Product Code: EAZ
• CFR Regulation Number: 872.4630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-14
• Decision Date: 1992-12-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06430035420247	K923462	000