ProTech Plus

Resin, Denture, Relining, Repairing, Rebasing

PROTECH PROFESSIONAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Protech Professional Products, Inc. with the FDA for Protech Plus.

Pre-market Notification Details

• Device ID: K151646
• 510k Number: K151646
• Device Name: ProTech Plus
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: PROTECH PROFESSIONAL PRODUCTS, INC. 2900 N.W. COMMERCE PARK DRIVE, STE 10 Boynton Beach, FL 33426
• Contact: Adam Bloch
• Correspondent: Blix Winston; ACDM CONSULTING LLC 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-18
• Decision Date: 2015-10-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D814SRHP1C1	K151646	000
D814SRC11C1	K151646	000
D814SBT121	K151646	000
D814SBT111	K151646	000
D814SBL121	K151646	000
D814SBL111	K151646	000
D814SBA121	K151646	000
D814SBA111	K151646	000
D814RUCPOLB1	K151646	000
D814RUCPOA11	K151646	000
D814RUCPOA1	K151646	000
D814RUCPO1	K151646	000
D814RUCOWOLB1	K151646	000
D814RUCOWOA11	K151646	000
D814RUCOWA1	K151646	000
D814RUCOW1	K151646	000
D814SRC11PV1	K151646	000
D814SRC12C1	K151646	000
D814SRH13PV1	K151646	000
D814SRH13C1	K151646	000
D814SRH12PV1	K151646	000
D814SRH12C1	K151646	000
D814SRH11PV1	K151646	000
D814SRH11C1	K151646	000
D814SRCP5PV1	K151646	000
D814SRCP5C1	K151646	000
D814SRCP3PV1	K151646	000
D814SRCP3C1	K151646	000
D814SRCP2PV1	K151646	000
D814SRCP2C1	K151646	000
D814SRCP1PV1	K151646	000
D814SRCP1C1	K151646	000
D814SRC12PV1	K151646	000
D814RUCDILB1	K151646	000
D814RUCDIA11	K151646	000
D814RUCDIA1	K151646	000
D814PLU13F1	K151646	000
D814PLU12GD1	K151646	000
D814PLU12F1	K151646	000
D814PLU12D1	K151646	000
D814PLU12A1	K151646	000
D814PLU121	K151646	000
D814LRH141	K151646	000
D814LRH131	K151646	000
D814LRH121	K151646	000
D814LRH111	K151646	000
D814LRH101	K151646	000
D814LRC141	K151646	000
D814LRC131	K151646	000
D814LRC121	K151646	000
D814LRC111	K151646	000
D814PLU13GA1	K151646	000
D814PLU13GC1	K151646	000
D814RUCDI1	K151646	000
D814RUC87LB1	K151646	000
D814RUC87A11	K151646	000
D814RUC871	K151646	000
D814RUC81LB1	K151646	000
D814RUC11C21	K151646	000
D814RUC11C11	K151646	000
D814PLU15GL1	K151646	000
D814PLU15G1	K151646	000
D814PLU15F1	K151646	000
D814PLU14GL1	K151646	000
D814PLU14GC1	K151646	000
D814PLU14F1	K151646	000
D814PLU13GL1	K151646	000
D814PLU13GD1	K151646	000
D814LRC101	K151646	000
D814SRC13PV1	K151646	000
D814RUC69A11	K151646	000
D814RUC69A1	K151646	000
D814RUC691	K151646	000
D814RUC67LB1	K151646	000
D814RUC67A11	K151646	000
D814RUC67A1	K151646	000
D814RUC671	K151646	000
D814RUC66LB1	K151646	000
D814RUC66A11	K151646	000
D814RUC66A1	K151646	000
D814RUC661	K151646	000
D814RUC65LB1	K151646	000
D814RUC65A11	K151646	000
D814RUC65A1	K151646	000
D814RUC651	K151646	000
D814RUC69LB1	K151646	000
D814RUC771	K151646	000
D814SRC13C1	K151646	000
D814RUCVPG1	K151646	000
D814RUCV11GL1	K151646	000
D814RUCV11GD1	K151646	000
D814RUCV11GC1	K151646	000
D814RUCV11GA1	K151646	000
D814RUCV11G1	K151646	000
D814RUCV11F1	K151646	000
D814RUC87A1	K151646	000
D814RUC81A11	K151646	000
D814RUC81A1	K151646	000
D814RUC811	K151646	000
D814RUC77LB1	K151646	000
D814RUC77A11	K151646	000
D814RUC77A1	K151646	000
D814RUC62LB1	K151646	000
D814RUC62A11	K151646	000
D814RUC62A1	K151646	000
D814PLU14GA1	K151646	000
D814PLU14G1	K151646	000
D814PLU13G1	K151646	000
D814PLU12L1	K151646	000
D814PLU12GL1	K151646	000
D814PLU12GC1	K151646	000
D814PLU12G1	K151646	000
D814PLU12C1	K151646	000
D814SRSB1	K151646	000
D814SRHP5PV1	K151646	000
D814SRHP5C1	K151646	000
D814SRHP3PV1	K151646	000
D814SRHP3C1	K151646	000
D814SRHP2PV1	K151646	000
D814SRHP2C1	K151646	000
D814PLU14GD1	K151646	000
D814PLU15GA1	K151646	000
D814RUC621	K151646	000
D814RUC59LB1	K151646	000
D814RUC59A11	K151646	000
D814RUC59A1	K151646	000
D814RUC595LB1	K151646	000
D814RUC591	K151646	000
D814RUC11GL1	K151646	000
D814RUC11GD1	K151646	000
D814RUC11GC1	K151646	000
D814RUC11GA1	K151646	000
D814RUC11G1	K151646	000
D814RUC11F1	K151646	000
D814RAL121	K151646	000
D814PLU15GD1	K151646	000
D814PLU15GC1	K151646	000
D814SRHP1PV1	K151646	000