ESTELITE FLOW QUICK

Material, Tooth Shade, Resin

TOKUYAMA DENTAL CORPORATION

The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Estelite Flow Quick.

Pre-market Notification Details

• Device ID: K051808
• 510k Number: K051808
• Device Name: ESTELITE FLOW QUICK
• Classification: Material, Tooth Shade, Resin
• Applicant: TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005
• Contact: Keith A Barritt
• Correspondent: Keith A Barritt; TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-05
• Decision Date: 2005-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04548190120215	K051808	000
04548190120338	K051808	000
04548190120345	K051808	000
04548190120352	K051808	000
04548190120369	K051808	000
04548190120376	K051808	000
04548190120819	K051808	000
04548190120826	K051808	000
04548190120833	K051808	000
04548190120840	K051808	000
04548190120321	K051808	000
04548190120314	K051808	000
04548190120222	K051808	000
04548190120239	K051808	000
04548190120246	K051808	000
04548190120253	K051808	000
04548190120260	K051808	000
04548190120277	K051808	000
04548190120284	K051808	000
04548190120291	K051808	000
04548190120307	K051808	000
04548190121113	K051808	000
04548190121120	K051808	000
04548190121243	K051808	000
04548190121250	K051808	000
04548190121267	K051808	000
04548190121274	K051808	000
04548190121717	K051808	000
04548190121724	K051808	000
04548190121731	K051808	000
04548190121748	K051808	000
04548190123810	K051808	000
04548190121236	K051808	000
04548190121229	K051808	000
04548190121137	K051808	000
04548190121144	K051808	000
04548190121151	K051808	000
04548190121168	K051808	000
04548190121175	K051808	000
04548190121182	K051808	000
04548190121199	K051808	000
04548190121205	K051808	000
04548190121212	K051808	000
04548190123919	K051808	000