Yamahachi Pink CAD/CAM Disk

Resin, Denture, Relining, Repairing, Rebasing

Yamahachi Dental Mfg., Co.

The following data is part of a premarket notification filed by Yamahachi Dental Mfg., Co. with the FDA for Yamahachi Pink Cad/cam Disk.

Pre-market Notification Details

• Device ID: K172683
• 510k Number: K172683
• Device Name: Yamahachi Pink CAD/CAM Disk
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: Yamahachi Dental Mfg., Co. 54-1, Ochigara Nishiura-Cho Gamamori-city, JP 443-0105
• Contact: Shogo Muramatsu
• Correspondent: Joyce St. Germaine; Denterprise International, Inc./510k FDA Consulting 100 East Granada Blvd. Ormond Beach, FL 32176
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-06
• Decision Date: 2018-01-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D080XXPMD985M18VPN0	K172683	000
D080XXPMD95MM25VPN0	K172683	000
D080XXPMD95MM30VPN0	K172683	000
D080XXPMD985M20VPN0	K172683	000
D080XXPMD985M22VPN0	K172683	000
D080XXPMD985M25VPN0	K172683	000
D080XXPMD985M30VPN0	K172683	000
D080XXPMD985M35VPN0	K172683	000
D080XXJSP1PCS20CLE0	K172683	000
D080XXJSP1PCS20DRP0	K172683	000
D080XXJSP1PCS20LGT0	K172683	000
D080XXJSP1PCS20LRP0	K172683	000
D080XXJSP1PCS20ORG0	K172683	000
D080XXJSP1PCS25CLE0	K172683	000
D080XXPMD95MM22VPN0	K172683	000
D080XXPMD95MM20VPN0	K172683	000
D080XXPMD101M20VPN0	K172683	000
D080XXPMD101M13PV80	K172683	000
D080XXPMD101M20PV80	K172683	000
D080XXPMD95MM20PV80	K172683	000
D080XXPMD95MM22PV80	K172683	000
D080XXPMD95MM25PV80	K172683	000
D080XXPMD95MM30PV80	K172683	000
D080XXPMD985M18PV80	K172683	000
D080XXPMD985M20PV80	K172683	000
D080XXPMD985M22PV80	K172683	000
D080XXPMD985M25PV80	K172683	000
D080XXPMD985M30PV80	K172683	000
D080XXPMD985M35PV80	K172683	000
D080XXPMD101M13VPN0	K172683	000
D080XXJSP1PCS25DRP0	K172683	000
D080XXJSP1PCS25LGT0	K172683	000
04582275719093	K172683	000
04582275719109	K172683	000
04582275719116	K172683	000
04582275719727	K172683	000
04582275719796	K172683	000
04582275719840	K172683	000
04582275719888	K172683	000
04582275719895	K172683	000
04582275719901	K172683	000
04582275719918	K172683	000
04582275719925	K172683	000
04582275719932	K172683	000
04582275718874	K172683	000
04582275719086	K172683	000
04582275719079	K172683	000
04582275719062	K172683	000
D080XXJSP1PCS25LRP0	K172683	000
D080XXJSP1PCS25ORG0	K172683	000
D080XXJSP1PCS30CLE0	K172683	000
D080XXJSP1PCS30DRP0	K172683	000
D080XXJSP1PCS30LGT0	K172683	000
D080XXJSP1PCS30LRP0	K172683	000
D080XXJSP1PCS30ORG0	K172683	000
04582275718997	K172683	000
04582275719000	K172683	000
04582275719017	K172683	000
04582275719024	K172683	000
04582275719048	K172683	000
04582275719055	K172683	000
04582275718881	K172683	000