Plasdent Disposable Barrier Sleeves And Barrier Film

Dental Barriers And Sleeves

Plasdent Corporation

The following data is part of a premarket notification filed by Plasdent Corporation with the FDA for Plasdent Disposable Barrier Sleeves And Barrier Film.

Pre-market Notification Details

• Device ID: K201604
• 510k Number: K201604
• Device Name: Plasdent Disposable Barrier Sleeves And Barrier Film
• Classification: Dental Barriers And Sleeves
• Applicant: Plasdent Corporation 969 Price Street Pomona, CA 91767
• Contact: Belen G Walayat
• Correspondent: Belen G Walayat; Plasdent Corporation 969 Price Street Pomona, CA 91767
• Product Code: PEM
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-06-15
• Decision Date: 2020-12-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D832PS5402	K201604	000
D832PS3252	K201604	000
D832PS3212	K201604	000
D832PS0022	K201604	000
D832PS00012	K201604	000
D832IC209110	K201604	000
D832IC209090	K201604	000
D832IC208560	K201604	000
D832IC208552	K201604	000
D832IC208290	K201604	000
D832IC208100	K201604	000
D832IC208052	K201604	000
D832IC0852	K201604	000
D832IC0012	K201604	000
D832CL1020	K201604	000
D832CL1010	K201604	000
D832PS3272	K201604	000
D832PS3700	K201604	000
D832PS370LG0	K201604	000
D832PS5302	K201604	000
D832PS5202	K201604	000
D832PS5102	K201604	000
D832PS5002	K201604	000
D832PS47080	K201604	000
D832PS47070	K201604	000
D832PS47010	K201604	000
D832PS47000	K201604	000
D832PS46602	K201604	000
D832PS45502	K201604	000
D832PS45112	K201604	000
D832PS45002	K201604	000
D832PS3767WO2	K201604	000
D832PS37402	K201604	000
D832PS37202	K201604	000
D832CL1002	K201604	000
D832XSSUNI22	K201604	000
D832PSREGAM20	K201604	000
D832PSGXDR22	K201604	000
D832PSGXDR12	K201604	000
D832PSDEXISU0	K201604	000
D832PSDEXIS22	K201604	000
D832PSCYGNUS12	K201604	000
D832PS610022	K201604	000
D832PS610012	K201604	000
D832PS610002	K201604	000
D832IC210130	K201604	000
D832IC209870	K201604	000
D832IC209690	K201604	000
D832IC209640	K201604	000
D832IC209170	K201604	000
D832SS2000	K201604	000
D832PSSHICK12	K201604	000
D832PSSHICK22	K201604	000
D832PSSUNI20	K201604	000
D832XSSHICK22	K201604	000
D832XSSHICK12	K201604	000
D832XSREGAM22	K201604	000
D832XSGXDR22	K201604	000
D832XSGXDR12	K201604	000
D832XSDEXISU0	K201604	000
D832XSDEXIS22	K201604	000
D832XSCYGNUS12	K201604	000
D832XS610022	K201604	000
D832XS610012	K201604	000
D832XS610002	K201604	000
D832ST60062	K201604	000
D832ST40042	K201604	000
D832ST30032	K201604	000
D832ST20022	K201604	000
D721SS1000	K201604	000
D832PS55002	K201604	000
D832PS9030	K201604	000
D832THS16102	K201604	000
D832THS11822	K201604	000
D832THS08082	K201604	000
D832PS400S2	K201604	000
D832PS4002	K201604	000
D832PS1270C2	K201604	000
D832PS1250Y2	K201604	000
D832PS1250P2	K201604	000
D832PS1250O2	K201604	000
D832PS1250M2	K201604	000
D832PS1250G2	K201604	000
D832PS1250E2	K201604	000
D832PS1250CB0	K201604	000
D832PS1250C2	K201604	000
D832PS1250BB0	K201604	000
D832PS1012	K201604	000
D832PS1022	K201604	000
D832PS1052	K201604	000
D832PS9020	K201604	000
D832PS9010	K201604	000
D832PS900BG0	K201604	000
D832PS9000	K201604	000
D832PS6702	K201604	000
D832PS6602	K201604	000
D832PS6502	K201604	000
D832PS3850FT2	K201604	000
D832PS38502	K201604	000
D832PS38252	K201604	000
D832PS3800FT2	K201604	000
D832PS38002	K201604	000
D832PS28002	K201604	000
D832PS1102	K201604	000
D832PS1062	K201604	000
D832PS1250B2	K201604	000
D832PS1230C2	K201604	000
D832PS7002	K201604	000
D832PS320A2	K201604	000
D832PS3202	K201604	000
D832PS3102	K201604	000
D832PS3082	K201604	000
D832PS3002	K201604	000
D832PSLED2	K201604	000
D832PSDEMI2	K201604	000
D832PS7352	K201604	000
D832PS7300	K201604	000
D832PS55330	K201604	000
D832PS55220	K201604	000
D832PS55112	K201604	000
D832PS55050	K201604	000
D832PS55020	K201604	000
D832PS7102	K201604	000
D832PS7202	K201604	000
D832HPCOVR2	K201604	000
D832PS4252	K201604	000
D832PS410ST2	K201604	000
D832PS4102	K201604	000
D832PS4082	K201604	000
D832PS4052	K201604	000
D832PS11052	K201604	000
D832PS11002	K201604	000
D832PS328T2	K201604	000
D832PS328P2	K201604	000
D832PS3282	K201604	000
D832PS2042	K201604	000
D832PS2032	K201604	000
D832PS2022	K201604	000
D832PS2012	K201604	000
D832PS2002	K201604	000
D832PS55012	K201604	000