The following data is part of a premarket notification filed by Dental Direkt Gmbh with the FDA for Dd Cubex2.
| Device ID | K150196 |
| 510k Number | K150196 |
| Device Name: | DD CubeX2 |
| Classification | Powder, Porcelain |
| Applicant | DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge, DE 32139 |
| Contact | Uwe Greitens |
| Correspondent | Uwe Greitens DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 Spenge, DE 32139 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-29 |
| Decision Date | 2015-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDDIG8560141 | K150196 | 000 |
| EDDIG8560011 | K150196 | 000 |
| EDDIG8540171 | K150196 | 000 |
| EDDIG8540161 | K150196 | 000 |
| EDDIG8540151 | K150196 | 000 |
| EDDIG8540141 | K150196 | 000 |
| EDDIG8540131 | K150196 | 000 |
| EDDIG8540121 | K150196 | 000 |
| EDDIG8540111 | K150196 | 000 |
| EDDIG8540101 | K150196 | 000 |
| EDDIG8560021 | K150196 | 000 |
| EDDIG8560031 | K150196 | 000 |
| EDDIG8560041 | K150196 | 000 |
| EDDIG8560131 | K150196 | 000 |
| EDDIG8560121 | K150196 | 000 |
| EDDIG8560111 | K150196 | 000 |
| EDDIG8560101 | K150196 | 000 |
| EDDIG8560091 | K150196 | 000 |
| EDDIG8560081 | K150196 | 000 |
| EDDIG8560071 | K150196 | 000 |
| EDDIG8560061 | K150196 | 000 |
| EDDIG8560051 | K150196 | 000 |
| EDDIG8540091 | K150196 | 000 |
| EDDIG8540081 | K150196 | 000 |
| EDDIG8540071 | K150196 | 000 |
| EDDIG8520111 | K150196 | 000 |
| EDDIG8520101 | K150196 | 000 |
| EDDIG8520091 | K150196 | 000 |
| EDDIG8520081 | K150196 | 000 |
| EDDIG8520071 | K150196 | 000 |
| EDDIG8520061 | K150196 | 000 |
| EDDIG8520051 | K150196 | 000 |
| EDDIG8520041 | K150196 | 000 |
| EDDIG8520031 | K150196 | 000 |
| EDDIG8520121 | K150196 | 000 |
| EDDIG8520131 | K150196 | 000 |
| EDDIG8520141 | K150196 | 000 |
| EDDIG8540061 | K150196 | 000 |
| EDDIG8540051 | K150196 | 000 |
| EDDIG8540041 | K150196 | 000 |
| EDDIG8540031 | K150196 | 000 |
| EDDIG8540021 | K150196 | 000 |
| EDDIG8540011 | K150196 | 000 |
| EDDIG8520171 | K150196 | 000 |
| EDDIG8520161 | K150196 | 000 |
| EDDIG8520151 | K150196 | 000 |
| EDDIG8520021 | K150196 | 000 |
| EDDIG8560151 | K150196 | 000 |
| EDDILBS30A21 | K150196 | 000 |
| EDDILBS100B31 | K150196 | 000 |
| EDDILBS100B21 | K150196 | 000 |
| EDDILBS100B11 | K150196 | 000 |
| EDDILBS100A41 | K150196 | 000 |
| EDDILBS100A351 | K150196 | 000 |
| EDDILBS100A31 | K150196 | 000 |
| EDDILBS100A21 | K150196 | 000 |
| EDDILBS100A11 | K150196 | 000 |
| EDDILBS1000M31 | K150196 | 000 |
| EDDILBS100B41 | K150196 | 000 |
| EDDILBS100C11 | K150196 | 000 |
| EDDILBS100C21 | K150196 | 000 |
| EDDILBS30A11 | K150196 | 000 |
| EDDILBS300M31 | K150196 | 000 |
| EDDILBS300M21 | K150196 | 000 |
| EDDILBS300M11 | K150196 | 000 |
| EDDILBS100D41 | K150196 | 000 |
| EDDILBS100D31 | K150196 | 000 |
| EDDILBS100D21 | K150196 | 000 |
| EDDILBS100C41 | K150196 | 000 |
| EDDILBS100C31 | K150196 | 000 |
| EDDILBS1000M21 | K150196 | 000 |
| EDDILBS1000M11 | K150196 | 000 |
| EDDILBS0011 | K150196 | 000 |
| EDDILAE15SOB1 | K150196 | 000 |
| EDDILAE15SO1 | K150196 | 000 |
| EDDILAE15SC21 | K150196 | 000 |
| EDDILAE15SC11 | K150196 | 000 |
| EDDILAE15SA21 | K150196 | 000 |
| EDDILAE15SA11 | K150196 | 000 |
| EDDILAE100V1 | K150196 | 000 |
| EDDILAE0011 | K150196 | 000 |
| EDDIG8560171 | K150196 | 000 |
| EDDILAE30B1 | K150196 | 000 |
| EDDILAE30DB1 | K150196 | 000 |
| EDDILAE30DG1 | K150196 | 000 |
| EDDILAE30Y1 | K150196 | 000 |
| EDDILAE30V1 | K150196 | 000 |
| EDDILAE30P1 | K150196 | 000 |
| EDDILAE30O1 | K150196 | 000 |
| EDDILAE30LP1 | K150196 | 000 |
| EDDILAE30LG1 | K150196 | 000 |
| EDDILAE30LB1 | K150196 | 000 |
| EDDILAE30G1 | K150196 | 000 |
| EDDILAE30DP1 | K150196 | 000 |
| EDDIG8560161 | K150196 | 000 |
| EDDIG8520011 | K150196 | 000 |
| EDDIG7140101 | K150196 | 000 |
| EDDIG7120161 | K150196 | 000 |
| EDDIG7120151 | K150196 | 000 |
| EDDIG7120141 | K150196 | 000 |
| EDDIG7120131 | K150196 | 000 |
| EDDIG7120121 | K150196 | 000 |
| EDDIG7120111 | K150196 | 000 |
| EDDIG7120101 | K150196 | 000 |
| EDDIG7120091 | K150196 | 000 |
| EDDIG7120081 | K150196 | 000 |
| EDDIG7120171 | K150196 | 000 |
| EDDIG7121 | K150196 | 000 |
| EDDIG7131 | K150196 | 000 |
| EDDIG7140091 | K150196 | 000 |
| EDDIG7140081 | K150196 | 000 |
| EDDIG7140071 | K150196 | 000 |
| EDDIG7140061 | K150196 | 000 |
| EDDIG7140051 | K150196 | 000 |
| EDDIG7140041 | K150196 | 000 |
| EDDIG7140031 | K150196 | 000 |
| EDDIG7140021 | K150196 | 000 |
| EDDIG7140011 | K150196 | 000 |
| EDDIG7120071 | K150196 | 000 |
| EDDIG7120061 | K150196 | 000 |
| EDDIG7120051 | K150196 | 000 |
| EDDIG7100101 | K150196 | 000 |
| EDDIG7100091 | K150196 | 000 |
| EDDIG7100081 | K150196 | 000 |
| EDDIG7100071 | K150196 | 000 |
| EDDIG7100061 | K150196 | 000 |
| EDDIG7100051 | K150196 | 000 |
| EDDIG7100041 | K150196 | 000 |
| EDDIG7100031 | K150196 | 000 |
| EDDIG7100021 | K150196 | 000 |
| EDDIG7100111 | K150196 | 000 |
| EDDIG7100121 | K150196 | 000 |
| EDDIG7100131 | K150196 | 000 |
| EDDIG7120041 | K150196 | 000 |
| EDDIG7120031 | K150196 | 000 |
| EDDIG7120021 | K150196 | 000 |
| EDDIG7120011 | K150196 | 000 |
| EDDIG7111 | K150196 | 000 |
| EDDIG7101 | K150196 | 000 |
| EDDIG7100161 | K150196 | 000 |
| EDDIG7100151 | K150196 | 000 |
| EDDIG7100141 | K150196 | 000 |
| EDDIG7100011 | K150196 | 000 |
| EDDIG7140111 | K150196 | 000 |
| EDDIG7761 | K150196 | 000 |
| EDDIG7160091 | K150196 | 000 |
| EDDIG7160081 | K150196 | 000 |
| EDDIG7160071 | K150196 | 000 |
| EDDIG7160061 | K150196 | 000 |
| EDDIG7160051 | K150196 | 000 |
| EDDIG7160041 | K150196 | 000 |
| EDDIG7160031 | K150196 | 000 |
| EDDIG7160021 | K150196 | 000 |
| EDDIG7160011 | K150196 | 000 |
| EDDIG7160101 | K150196 | 000 |
| EDDIG7160111 | K150196 | 000 |
| EDDIG7160121 | K150196 | 000 |
| EDDIG7751 | K150196 | 000 |
| EDDIG7741 | K150196 | 000 |
| EDDIG7721 | K150196 | 000 |
| EDDIG7701 | K150196 | 000 |
| EDDIG7161 | K150196 | 000 |
| EDDIG7160161 | K150196 | 000 |
| EDDIG7160151 | K150196 | 000 |
| EDDIG7160141 | K150196 | 000 |
| EDDIG7160131 | K150196 | 000 |
| EDDIG7151 | K150196 | 000 |
| EDDIG7150171 | K150196 | 000 |
| EDDIG7150161 | K150196 | 000 |
| EDDIG7150031 | K150196 | 000 |
| EDDIG7150021 | K150196 | 000 |
| EDDIG7150011 | K150196 | 000 |
| EDDIG7141 | K150196 | 000 |
| EDDIG7140171 | K150196 | 000 |
| EDDIG7140161 | K150196 | 000 |
| EDDIG7140151 | K150196 | 000 |
| EDDIG7140141 | K150196 | 000 |
| EDDIG7140131 | K150196 | 000 |
| EDDIG7150041 | K150196 | 000 |
| EDDIG7150051 | K150196 | 000 |
| EDDIG7150061 | K150196 | 000 |
| EDDIG7150151 | K150196 | 000 |
| EDDIG7150141 | K150196 | 000 |
| EDDIG7150131 | K150196 | 000 |
| EDDIG7150121 | K150196 | 000 |
| EDDIG7150111 | K150196 | 000 |
| EDDIG7150101 | K150196 | 000 |
| EDDIG7150091 | K150196 | 000 |
| EDDIG7150081 | K150196 | 000 |
| EDDIG7150071 | K150196 | 000 |
| EDDIG7140121 | K150196 | 000 |
| EDDILBS30A31 | K150196 | 000 |
| EDDILZP0531 | K150196 | 000 |
| EDDILZE0031 | K150196 | 000 |
| EDDILZE0021 | K150196 | 000 |
| EDDILZE0011 | K150196 | 000 |
| EDDILZD0661 | K150196 | 000 |
| EDDILZD0651 | K150196 | 000 |
| EDDILZD0641 | K150196 | 000 |
| EDDILZD0631 | K150196 | 000 |
| EDDILZD0621 | K150196 | 000 |
| EDDILZD0611 | K150196 | 000 |
| EDDILZE0041 | K150196 | 000 |
| EDDILZE0051 | K150196 | 000 |
| EDDILZE0061 | K150196 | 000 |
| EDDILZP0511 | K150196 | 000 |
| EDDILZP0121 | K150196 | 000 |
| EDDILZP0111 | K150196 | 000 |
| EDDILZP0101 | K150196 | 000 |
| EDDILZP0091 | K150196 | 000 |
| EDDILZP0071 | K150196 | 000 |
| EDDILZP0051 | K150196 | 000 |
| EDDILZP0031 | K150196 | 000 |
| EDDILZP0011 | K150196 | 000 |
| EDDILZD0601 | K150196 | 000 |
| EDDILZD0591 | K150196 | 000 |
| EDDILZD0581 | K150196 | 000 |
| EDDILZD0111 | K150196 | 000 |
| EDDILZD0101 | K150196 | 000 |
| EDDILZD0091 | K150196 | 000 |
| EDDILZD0081 | K150196 | 000 |
| EDDILZD0071 | K150196 | 000 |
| EDDILZD0061 | K150196 | 000 |
| EDDILZD0051 | K150196 | 000 |
| EDDILZD0041 | K150196 | 000 |
| EDDILZD0031 | K150196 | 000 |
| EDDILZD0121 | K150196 | 000 |
| EDDILZD0131 | K150196 | 000 |
| EDDILZD0141 | K150196 | 000 |
| EDDILZD0571 | K150196 | 000 |
| EDDILZD0561 | K150196 | 000 |
| EDDILZD0551 | K150196 | 000 |
| EDDILZD0541 | K150196 | 000 |
| EDDILZD0531 | K150196 | 000 |
| EDDILZD0521 | K150196 | 000 |
| EDDILZD0511 | K150196 | 000 |
| EDDILZD0161 | K150196 | 000 |
| EDDILZD0151 | K150196 | 000 |
| EDDILZD0021 | K150196 | 000 |
| EDDILZP0551 | K150196 | 000 |
| H65890124190 | K150196 | 000 |
| H65890124020 | K150196 | 000 |
| H65890124010 | K150196 | 000 |
| H65890124000 | K150196 | 000 |
| H65890123980 | K150196 | 000 |
| H65890123970 | K150196 | 000 |
| H65890123960 | K150196 | 000 |
| H65890123950 | K150196 | 000 |
| H65890123940 | K150196 | 000 |
| H65890123920 | K150196 | 000 |
| H65890124030 | K150196 | 000 |
| H65890124050 | K150196 | 000 |
| H65890124060 | K150196 | 000 |
| H65890124160 | K150196 | 000 |
| H65890124150 | K150196 | 000 |
| H65890124140 | K150196 | 000 |
| H65890124130 | K150196 | 000 |
| H65890124120 | K150196 | 000 |
| H65890124110 | K150196 | 000 |
| H65890124100 | K150196 | 000 |
| H65890124090 | K150196 | 000 |
| H65890124080 | K150196 | 000 |
| H65890123910 | K150196 | 000 |
| H65890123900 | K150196 | 000 |
| H65890123890 | K150196 | 000 |
| EDDILZS0051 | K150196 | 000 |
| EDDILZS0041 | K150196 | 000 |
| EDDILZS0031 | K150196 | 000 |
| EDDILZS0021 | K150196 | 000 |
| EDDILZS0011 | K150196 | 000 |
| EDDILZP0621 | K150196 | 000 |
| EDDILZP0611 | K150196 | 000 |
| EDDILZP0601 | K150196 | 000 |
| EDDILZP0591 | K150196 | 000 |
| H65890123740 | K150196 | 000 |
| H65890123750 | K150196 | 000 |
| H65890123770 | K150196 | 000 |
| H65890123880 | K150196 | 000 |
| H65890123870 | K150196 | 000 |
| H65890123860 | K150196 | 000 |
| H65890123850 | K150196 | 000 |
| H65890123840 | K150196 | 000 |
| H65890123830 | K150196 | 000 |
| H65890123820 | K150196 | 000 |
| H65890123810 | K150196 | 000 |
| H65890123800 | K150196 | 000 |
| EDDILZP0571 | K150196 | 000 |
| EDDILZD0011 | K150196 | 000 |
| EDDILPSC30C21 | K150196 | 000 |
| EDDILPSC300M11 | K150196 | 000 |
| EDDILPSC100D41 | K150196 | 000 |
| EDDILPSC100D31 | K150196 | 000 |
| EDDILPSC100D21 | K150196 | 000 |
| EDDILPSC100C41 | K150196 | 000 |
| EDDILPSC100C31 | K150196 | 000 |
| EDDILPSC100C21 | K150196 | 000 |
| EDDILPSC100C11 | K150196 | 000 |
| EDDILPSC100B41 | K150196 | 000 |
| EDDILPSC300M21 | K150196 | 000 |
| EDDILPSC300M31 | K150196 | 000 |
| EDDILPSC30A11 | K150196 | 000 |
| EDDILPSC30C11 | K150196 | 000 |
| EDDILPSC30B41 | K150196 | 000 |
| EDDILPSC30B31 | K150196 | 000 |
| EDDILPSC30B21 | K150196 | 000 |
| EDDILPSC30B11 | K150196 | 000 |
| EDDILPSC30A41 | K150196 | 000 |
| EDDILPSC30A351 | K150196 | 000 |
| EDDILPSC30A31 | K150196 | 000 |
| EDDILPSC30A21 | K150196 | 000 |
| EDDILPSC100B31 | K150196 | 000 |
| EDDILPSC100B21 | K150196 | 000 |
| EDDILPSC100B11 | K150196 | 000 |
| EDDILBS30C41 | K150196 | 000 |
| EDDILBS30C31 | K150196 | 000 |
| EDDILBS30C21 | K150196 | 000 |
| EDDILBS30C11 | K150196 | 000 |
| EDDILBS30B41 | K150196 | 000 |
| EDDILBS30B31 | K150196 | 000 |
| EDDILBS30B21 | K150196 | 000 |
| EDDILBS30B11 | K150196 | 000 |
| EDDILBS30A41 | K150196 | 000 |
| EDDILBS30D21 | K150196 | 000 |
| EDDILBS30D31 | K150196 | 000 |
| EDDILBS30D41 | K150196 | 000 |
| EDDILPSC100A41 | K150196 | 000 |
| EDDILPSC100A351 | K150196 | 000 |
| EDDILPSC100A31 | K150196 | 000 |
| EDDILPSC100A21 | K150196 | 000 |
| EDDILPSC100A11 | K150196 | 000 |
| EDDILPSC1000M31 | K150196 | 000 |
| EDDILPSC1000M21 | K150196 | 000 |
| EDDILPSC1000M11 | K150196 | 000 |
| EDDILPSC0011 | K150196 | 000 |
| EDDILBS30A351 | K150196 | 000 |
| EDDILPSC30C31 | K150196 | 000 |
| EDDILZ0031 | K150196 | 000 |
| EDDILPSZ30B21 | K150196 | 000 |
| EDDILPSZ30B11 | K150196 | 000 |
| EDDILPSZ30A41 | K150196 | 000 |
| EDDILPSZ30A351 | K150196 | 000 |
| EDDILPSZ30A31 | K150196 | 000 |
| EDDILPSZ30A21 | K150196 | 000 |
| EDDILPSZ30A11 | K150196 | 000 |
| EDDILPSZ300M31 | K150196 | 000 |
| EDDILPSZ300M21 | K150196 | 000 |
| EDDILPSZ30B31 | K150196 | 000 |
| EDDILPSZ30B41 | K150196 | 000 |
| EDDILPSZ30C11 | K150196 | 000 |
| EDDILZ0021 | K150196 | 000 |
| EDDILV0021 | K150196 | 000 |
| EDDILV0011 | K150196 | 000 |
| EDDILPSZ30D41 | K150196 | 000 |
| EDDILPSZ30D31 | K150196 | 000 |
| EDDILPSZ30D21 | K150196 | 000 |
| EDDILPSZ30C41 | K150196 | 000 |
| EDDILPSZ30C31 | K150196 | 000 |
| EDDILPSZ30C21 | K150196 | 000 |
| EDDILPSZ300M11 | K150196 | 000 |
| EDDILPSZ100D41 | K150196 | 000 |
| EDDILPSZ100D31 | K150196 | 000 |
| EDDILPSZ100A21 | K150196 | 000 |
| EDDILPSZ100A11 | K150196 | 000 |
| EDDILPSZ1000M31 | K150196 | 000 |
| EDDILPSZ1000M21 | K150196 | 000 |
| EDDILPSZ1000M11 | K150196 | 000 |
| EDDILPSZ0011 | K150196 | 000 |
| EDDILPSC30D41 | K150196 | 000 |
| EDDILPSC30D31 | K150196 | 000 |
| EDDILPSC30D21 | K150196 | 000 |
| EDDILPSZ100A31 | K150196 | 000 |
| EDDILPSZ100A351 | K150196 | 000 |
| EDDILPSZ100A41 | K150196 | 000 |
| EDDILPSZ100D21 | K150196 | 000 |
| EDDILPSZ100C41 | K150196 | 000 |
| EDDILPSZ100C31 | K150196 | 000 |
| EDDILPSZ100C21 | K150196 | 000 |
| EDDILPSZ100C11 | K150196 | 000 |
| EDDILPSZ100B41 | K150196 | 000 |
| EDDILPSZ100B31 | K150196 | 000 |
| EDDILPSZ100B21 | K150196 | 000 |
| EDDILPSZ100B11 | K150196 | 000 |
| EDDILPSC30C41 | K150196 | 000 |