The following data is part of a premarket notification filed by J.b.c And Co. with the FDA for Jet Acrylic Liquid-monomer, Ortho Jet Powder-polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, Metr.
Device ID | K974727 |
510k Number | K974727 |
Device Name: | JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | J.B.C AND CO. 23691 VIA DEL RIO Yorba Linda, CA 92887 |
Contact | Priscilla L Mier |
Correspondent | Priscilla L Mier J.B.C AND CO. 23691 VIA DEL RIO Yorba Linda, CA 92887 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-18 |
Decision Date | 1998-02-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D85140 | K974727 | 000 |
D851905 | K974727 | 000 |
D851906 | K974727 | 000 |
D851A00 | K974727 | 000 |
D851AA0 | K974727 | 000 |
D851B0 | K974727 | 000 |
D851BB0 | K974727 | 000 |
D851BC0 | K974727 | 000 |
D851BMLTP0 | K974727 | 000 |
D8515050 | K974727 | 000 |
D85148 | K974727 | 000 |
D85147 | K974727 | 000 |
D851401 | K974727 | 000 |
D85141 | K974727 | 000 |
D851416 | K974727 | 000 |
D85142 | K974727 | 000 |
D851431 | K974727 | 000 |
D85144 | K974727 | 000 |
D85145 | K974727 | 000 |
D85146 | K974727 | 000 |
D851BMMG0 | K974727 | 000 |
D851BMMP0 | K974727 | 000 |
D851DPFAS0 | K974727 | 000 |
D851DPFLT0 | K974727 | 000 |
D851DPFP01 | K974727 | 000 |
D851DPFP04 | K974727 | 000 |
D851DPFRP0 | K974727 | 000 |
D851DPFSP99 | K974727 | 000 |
D851E0 | K974727 | 000 |
D851EE0 | K974727 | 000 |
D851DPFA0 | K974727 | 000 |
D851DPF0 | K974727 | 000 |
D851DP431 | K974727 | 000 |
D851BS1 | K974727 | 000 |
D851BS2 | K974727 | 000 |
D851BS3 | K974727 | 000 |
D851BS4 | K974727 | 000 |
D851C0 | K974727 | 000 |
D851D0 | K974727 | 000 |
D851DD0 | K974727 | 000 |
D851DP0 | K974727 | 000 |
D851F0 | K974727 | 000 |
D85101 | K974727 | 000 |
D851122TEAL0 | K974727 | 000 |
D851123MAROON0 | K974727 | 000 |
D85113 | K974727 | 000 |
D85114 | K974727 | 000 |
D85114SLATE0 | K974727 | 000 |
D85115 | K974727 | 000 |
D85116 | K974727 | 000 |
D85117 | K974727 | 000 |
D85112 | K974727 | 000 |
D85111 | K974727 | 000 |
D85110 | K974727 | 000 |
D85102 | K974727 | 000 |
D85103 | K974727 | 000 |
D85104 | K974727 | 000 |
D85105 | K974727 | 000 |
D85106 | K974727 | 000 |
D85107 | K974727 | 000 |
D85108 | K974727 | 000 |
D85109 | K974727 | 000 |
D85118 | K974727 | 000 |
D85119 | K974727 | 000 |
D85131 | K974727 | 000 |
D85132 | K974727 | 000 |
D85133 | K974727 | 000 |
D85134 | K974727 | 000 |
D85135 | K974727 | 000 |
D85136 | K974727 | 000 |
D85137 | K974727 | 000 |
D85138 | K974727 | 000 |
D85130 | K974727 | 000 |
D85129 | K974727 | 000 |
D85128 | K974727 | 000 |
D85120 | K974727 | 000 |
D85121 | K974727 | 000 |
D85122 | K974727 | 000 |
D85123 | K974727 | 000 |
D85124 | K974727 | 000 |
D85125 | K974727 | 000 |
D85126 | K974727 | 000 |
D85127 | K974727 | 000 |
D85139 | K974727 | 000 |
D851Q0 | K974727 | 000 |
D851SP317 | K974727 | 000 |
D851SP319 | K974727 | 000 |
D851SP320 | K974727 | 000 |
D851SP322 | K974727 | 000 |
D851SP324 | K974727 | 000 |
D851SP325 | K974727 | 000 |
D851SP326 | K974727 | 000 |
D851SP327 | K974727 | 000 |
D851SP315 | K974727 | 000 |
D851SP314 | K974727 | 000 |
D851SP313 | K974727 | 000 |
D851QQ0 | K974727 | 000 |
D851R0 | K974727 | 000 |
D851RR0 | K974727 | 000 |
D851S0 | K974727 | 000 |
D851SLT0 | K974727 | 000 |
D851SP310 | K974727 | 000 |
D851SP311 | K974727 | 000 |
D851SP312 | K974727 | 000 |
D851SP328 | K974727 | 000 |
D851SP329 | K974727 | 000 |
D851TS77 | K974727 | 000 |
D851TS81 | K974727 | 000 |
D851U0 | K974727 | 000 |
D851V0 | K974727 | 000 |
D851W0 | K974727 | 000 |
D851X0 | K974727 | 000 |
D851Y0 | K974727 | 000 |
D851Z0 | K974727 | 000 |
D851TS69 | K974727 | 000 |
D851TS68 | K974727 | 000 |
D851TS67 | K974727 | 000 |
D851SP330 | K974727 | 000 |
D851SP331 | K974727 | 000 |
D851T0 | K974727 | 000 |
D851TS59 | K974727 | 000 |
D851TS61 | K974727 | 000 |
D851TS62 | K974727 | 000 |
D851TS65 | K974727 | 000 |
D851TS66 | K974727 | 000 |
D851ZU0 | K974727 | 000 |
D851FF0 | K974727 | 000 |
D851M0 | K974727 | 000 |
D851MM0 | K974727 | 000 |
D851MR56 | K974727 | 000 |
D851MR57 | K974727 | 000 |
D851MR59 | K974727 | 000 |
D851MR60 | K974727 | 000 |
D851MR64 | K974727 | 000 |
D851MR69 | K974727 | 000 |
D851L0 | K974727 | 000 |
D851KK0 | K974727 | 000 |
D851K0 | K974727 | 000 |
D851G0 | K974727 | 000 |
D851GG0 | K974727 | 000 |
D851GOLD0 | K974727 | 000 |
D851H0 | K974727 | 000 |
D851HH0 | K974727 | 000 |
D851I0 | K974727 | 000 |
D851J0 | K974727 | 000 |
D851JJ0 | K974727 | 000 |
D851MR70 | K974727 | 000 |
D851MR72 | K974727 | 000 |
D851P0 | K974727 | 000 |
D851PS1 | K974727 | 000 |
D851PS2 | K974727 | 000 |
D851PS3 | K974727 | 000 |
D851PS4 | K974727 | 000 |
D851PS5 | K974727 | 000 |
D851PS6 | K974727 | 000 |
D851PS7 | K974727 | 000 |
D851O0 | K974727 | 000 |
D851NN0 | K974727 | 000 |
D851NEO905 | K974727 | 000 |
D851MR74 | K974727 | 000 |
D851MR80 | K974727 | 000 |
D851MR83 | K974727 | 000 |
D851MR88 | K974727 | 000 |
D851MR90 | K974727 | 000 |
D851MR92 | K974727 | 000 |
D851MR93 | K974727 | 000 |
D851N0 | K974727 | 000 |
D851PS8 | K974727 | 000 |