SM INTERNAL./EXTERNAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

DIO DEPARTMENT DSI, INC.

The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Sm Internal./external Implant System.

Pre-market Notification Details

Device IDK070569
510k NumberK070569
Device Name:SM INTERNAL./EXTERNAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs,  CA  90670
ContactKenny Lim
CorrespondentKenny Lim
DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs,  CA  90670
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-28
Decision Date2007-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806195916230 K070569 000
08800049407240 K070569 000
08800049405000 K070569 000
08800049404959 K070569 000
08800049404898 K070569 000
08800049404843 K070569 000
08800049404140 K070569 000
08800049404133 K070569 000
08800049404126 K070569 000
08800049404072 K070569 000
08800049404065 K070569 000
08800049404058 K070569 000
08800049404041 K070569 000
08800049404034 K070569 000
08800049404027 K070569 000
08800049404010 K070569 000
08800049404003 K070569 000
08800049407257 K070569 000
08800049407301 K070569 000
08800049428825 K070569 000
08800049427248 K070569 000
08800049427231 K070569 000
08800049427224 K070569 000
08800049427217 K070569 000
08800049427200 K070569 000
08800049427194 K070569 000
08800049427187 K070569 000
08800049427170 K070569 000
08800049407455 K070569 000
08800049407448 K070569 000
08800049407356 K070569 000
08800049407349 K070569 000
08800049407332 K070569 000
08800049407325 K070569 000
08800049407318 K070569 000
08800049403990 K070569 000
08800049403983 K070569 000
08800049403976 K070569 000
08800049287033 K070569 000
08800049286982 K070569 000
08800049286975 K070569 000
08800049286937 K070569 000
08800049286913 K070569 000
08800049286906 K070569 000
08800049286883 K070569 000
08800049286876 K070569 000
08800049286852 K070569 000
08800049286845 K070569 000
08800049286821 K070569 000
08800049286760 K070569 000
08800049286463 K070569 000
08800049286456 K070569 000
08800049286449 K070569 000
08800049286432 K070569 000
08800049287057 K070569 000
08800049287064 K070569 000
08800049403969 K070569 000
08800049403785 K070569 000
08800049403716 K070569 000
08800049287750 K070569 000
08800049287743 K070569 000
08800049287736 K070569 000
08800049287163 K070569 000
08800049287156 K070569 000
08800049287149 K070569 000
08800049287132 K070569 000
08800049287125 K070569 000
08800049287118 K070569 000
08800049287101 K070569 000
08800049287095 K070569 000
08800049287088 K070569 000
08800049287071 K070569 000
08800049286425 K070569 000
08806195916346 K070569 000
08806195927984 K070569 000
08806195927793 K070569 000
08806195927786 K070569 000
08806195927779 K070569 000
08806195927762 K070569 000
08806195927755 K070569 000
08806195927748 K070569 000
08806195927731 K070569 000
08806195927724 K070569 000
08806195927717 K070569 000
08806195927700 K070569 000
08806195927694 K070569 000
08806195927687 K070569 000
08806195927670 K070569 000
08806195927311 K070569 000
08806195927304 K070569 000
08806195927298 K070569 000
08806195927809 K070569 000
08806195927816 K070569 000
08806195927977 K070569 000
08806195927960 K070569 000
08806195927953 K070569 000
08806195927946 K070569 000
08806195927939 K070569 000
08806195927922 K070569 000
08806195927915 K070569 000
08806195927908 K070569 000
08806195927892 K070569 000
08806195927885 K070569 000
08806195927878 K070569 000
08806195927861 K070569 000
08806195927854 K070569 000
08806195927847 K070569 000
08806195927830 K070569 000
08806195927823 K070569 000
08806195927199 K070569 000
08806195927151 K070569 000
08806195927144 K070569 000
08806195926628 K070569 000
08806195926611 K070569 000
08806195926581 K070569 000
08806195926567 K070569 000
08806195926543 K070569 000
08806195926529 K070569 000
08806195927168 K070569 000
08806195926475 K070569 000
08806195926468 K070569 000
08806195926451 K070569 000
08806195926444 K070569 000
08806195917534 K070569 000
08806195916896 K070569 000
08806195916889 K070569 000
08806195916858 K070569 000
08806195916841 K070569 000
08806195926666 K070569 000
08806195926673 K070569 000
08806195927137 K070569 000
08806195927120 K070569 000
08806195927113 K070569 000
08806195927106 K070569 000
08806195927090 K070569 000
08806195927083 K070569 000
08806195926970 K070569 000
08806195926963 K070569 000
08806195926925 K070569 000
08806195926918 K070569 000
08806195926840 K070569 000
08806195926833 K070569 000
08806195926765 K070569 000
08806195926758 K070569 000
08806195926741 K070569 000
08806195926734 K070569 000
08806195916360 K070569 000
08800049271445 K070569 000
08800049235478 K070569 000
08800049235461 K070569 000
08800049235454 K070569 000
08800049235447 K070569 000
08800049235430 K070569 000
08800049235379 K070569 000
08800049235362 K070569 000
08800049235355 K070569 000
08800049235348 K070569 000
08800049235331 K070569 000
08800049235324 K070569 000
08800049235317 K070569 000
08800049235300 K070569 000
08800049235294 K070569 000
08800049235287 K070569 000
08800049235270 K070569 000
08800049235485 K070569 000
08800049236277 K070569 000
08800049271438 K070569 000
08800049271421 K070569 000
08800049271414 K070569 000
08800049252109 K070569 000
08800049245408 K070569 000
08800049245392 K070569 000
08800049245385 K070569 000
08800049242292 K070569 000
08800049242032 K070569 000
08800049242025 K070569 000
08800049242018 K070569 000
08800049236345 K070569 000
08800049236338 K070569 000
08800049236321 K070569 000
08800049236291 K070569 000
08800049236284 K070569 000
08800049235263 K070569 000
08800049235256 K070569 000
08800049235232 K070569 000
08800049233726 K070569 000
08800049233719 K070569 000
08800049233696 K070569 000
08800049233672 K070569 000
08800049233658 K070569 000
08800049233634 K070569 000
08800049233610 K070569 000
08800049233597 K070569 000
08800049233573 K070569 000
08800049233559 K070569 000
08800049233504 K070569 000
08800049233498 K070569 000
08800049233429 K070569 000
08800049233412 K070569 000
08800049233368 K070569 000
08800049233351 K070569 000
08800049233733 K070569 000
08800049233740 K070569 000
08800049235225 K070569 000
08800049235218 K070569 000
08800049235201 K070569 000
08800049235195 K070569 000
08800049235188 K070569 000
08800049235171 K070569 000
08800049235164 K070569 000
08800049235157 K070569 000
08800049235140 K070569 000
08800049235133 K070569 000
08800049234983 K070569 000
08800049234952 K070569 000
08800049233832 K070569 000
08800049233818 K070569 000
08800049233801 K070569 000
08800049233795 K070569 000
08800049233344 K070569 000
08800049273623 K070569 000
08800049286265 K070569 000
08800049279687 K070569 000
08800049279670 K070569 000
08800049279557 K070569 000
08800049279540 K070569 000
08800049279533 K070569 000
08800049279526 K070569 000
08800049279519 K070569 000
08800049279502 K070569 000
08800049279496 K070569 000
08800049279489 K070569 000
08800049279472 K070569 000
08800049279465 K070569 000
08800049279458 K070569 000
08800049279441 K070569 000
08800049279434 K070569 000
08800049279427 K070569 000
08800049279717 K070569 000
08800049279724 K070569 000
08800049286234 K070569 000
08800049286227 K070569 000
08800049286203 K070569 000
08800049286197 K070569 000
08800049286180 K070569 000
08800049286173 K070569 000
08800049286067 K070569 000
08800049286043 K070569 000
08800049281734 K070569 000
08800049281727 K070569 000
08800049281710 K070569 000
08800049281703 K070569 000
08800049279809 K070569 000
08800049279793 K070569 000
08800049279755 K070569 000
08800049279748 K070569 000
08800049279410 K070569 000
08800049279403 K070569 000
08800049279397 K070569 000
08800049274644 K070569 000
08800049274637 K070569 000
08800049273975 K070569 000
08800049273951 K070569 000
08800049273944 K070569 000
08800049273937 K070569 000
08800049273791 K070569 000
08800049273784 K070569 000
08800049273760 K070569 000
08800049273753 K070569 000
08800049273739 K070569 000
08800049273722 K070569 000
08800049273708 K070569 000
08800049273685 K070569 000
08800049273678 K070569 000
08800049273661 K070569 000
08800049274651 K070569 000
08800049274668 K070569 000
08800049279380 K070569 000
08800049279359 K070569 000
08800049279342 K070569 000
08800049279304 K070569 000
08800049279298 K070569 000
08800049279199 K070569 000
08800049279182 K070569 000
08800049279113 K070569 000
08800049279106 K070569 000
08800049279090 K070569 000
08800049279083 K070569 000
08800049279076 K070569 000
08800049279069 K070569 000
08800049279052 K070569 000
08800049274682 K070569 000
08800049274675 K070569 000
08800049273630 K070569 000
08806195928820 K070569 000
08806195928547 K070569 000
08806195928530 K070569 000
08806195928523 K070569 000
08806195928516 K070569 000
08806195928509 K070569 000
08806195928493 K070569 000
08806195928486 K070569 000
08806195928479 K070569 000
08806195927663 K070569 000
08806195927656 K070569 000
08806195927649 K070569 000
08806195927632 K070569 000
08806195927625 K070569 000
08806195927618 K070569 000
08806195927601 K070569 000
08806195927595 K070569 000
08806195928554 K070569 000
08806195928561 K070569 000
08806195928813 K070569 000
08806195928806 K070569 000
08806195928790 K070569 000
08806195928707 K070569 000
08806195928691 K070569 000
08806195928684 K070569 000
08806195928677 K070569 000
08806195928660 K070569 000
08806195928653 K070569 000
08806195928646 K070569 000
08806195928639 K070569 000
08806195928622 K070569 000
08806195928615 K070569 000
08806195928592 K070569 000
08806195928585 K070569 000
08806195928578 K070569 000
08806195927588 K070569 000
08806195927571 K070569 000
08806195927564 K070569 000
08806195927373 K070569 000
08806195927281 K070569 000
08806195927274 K070569 000
08806195927267 K070569 000
08806195927250 K070569 000
08806195927243 K070569 000
08806195927236 K070569 000
08806195927229 K070569 000
08806195927212 K070569 000
08806195927205 K070569 000
08806195927182 K070569 000
08806195927175 K070569 000
08806195927038 K070569 000
08806195927021 K070569 000
08806195927014 K070569 000
08806195926956 K070569 000
08806195927380 K070569 000
08806195927397 K070569 000
08806195927557 K070569 000
08806195927540 K070569 000
08806195927533 K070569 000
08806195927526 K070569 000
08806195927519 K070569 000
08806195927502 K070569 000
08806195927496 K070569 000
08806195927489 K070569 000
08806195927472 K070569 000
08806195927465 K070569 000
08806195927458 K070569 000
08806195927441 K070569 000
08806195927434 K070569 000
08806195927427 K070569 000
08806195927410 K070569 000
08806195927403 K070569 000
08806195926949 K070569 000
08806195928837 K070569 000
08806195929612 K070569 000
08806195929568 K070569 000
08806195929551 K070569 000
08806195929544 K070569 000
08806195929537 K070569 000
08806195929520 K070569 000
08806195929513 K070569 000
08806195929506 K070569 000
08806195929490 K070569 000
08806195929483 K070569 000
08806195929476 K070569 000
08806195929469 K070569 000
08806195929452 K070569 000
08806195929445 K070569 000
08806195929438 K070569 000
08806195929414 K070569 000
08806195929407 K070569 000
08806195929575 K070569 000
08806195929582 K070569 000
08806195929605 K070569 000
08806195929599 K070569 000
08806195929421 K070569 000
08806195929780 K070569 000
08806195929773 K070569 000
08806195929766 K070569 000
08806195929759 K070569 000
08806195929742 K070569 000
08806195929735 K070569 000
08806195929728 K070569 000
08806195929711 K070569 000
08806195929698 K070569 000
08806195929667 K070569 000
08806195929643 K070569 000
08806195929636 K070569 000
08806195929629 K070569 000
08806195929391 K070569 000
08806195929384 K070569 000
08806195929377 K070569 000
08806195929070 K070569 000
08806195929063 K070569 000
08806195929056 K070569 000
08806195929049 K070569 000
08806195929032 K070569 000
08806195929025 K070569 000
08806195929018 K070569 000
08806195929001 K070569 000
08806195928998 K070569 000
08806195928981 K070569 000
08806195928974 K070569 000
08806195928967 K070569 000
08806195928882 K070569 000
08806195928875 K070569 000
08806195928868 K070569 000
08806195928851 K070569 000
08806195929087 K070569 000
08806195929094 K070569 000
08806195929360 K070569 000
08806195929353 K070569 000
08806195929346 K070569 000
08806195929339 K070569 000
08806195929308 K070569 000
08806195929292 K070569 000
08806195929285 K070569 000
08806195929186 K070569 000
08806195929179 K070569 000
08806195929162 K070569 000
08806195929155 K070569 000
08806195929148 K070569 000
08806195929131 K070569 000
08806195929124 K070569 000
08806195929117 K070569 000
08806195929100 K070569 000
08806195928844 K070569 000
08806195917046 K070569 000
08806195928783 K070569 000
08806195928769 K070569 000
08806195928752 K070569 000
08806195928745 K070569 000
08806195928738 K070569 000
08806195928721 K070569 000
08806195928714 K070569 000
08806195928462 K070569 000
08806195928455 K070569 000
08806195928448 K070569 000
08806195928431 K070569 000
08806195928424 K070569 000
08806195928417 K070569 000
08806195928400 K070569 000
08806195928394 K070569 000
08806195928387 K070569 000
08806195928929 K070569 000
08806195928936 K070569 000
08806195917022 K070569 000
08806195929704 K070569 000
08806195929681 K070569 000
08806195929674 K070569 000
08806195929650 K070569 000
08806195929322 K070569 000
08806195929315 K070569 000
08806195929278 K070569 000
08806195929261 K070569 000
08806195929254 K070569 000
08806195929247 K070569 000
08806195929230 K070569 000
08806195929223 K070569 000
08806195929216 K070569 000
08806195929209 K070569 000
08806195929193 K070569 000
08806195928370 K070569 000
08806195928363 K070569 000
08806195928356 K070569 000
08806195928158 K070569 000
08806195928141 K070569 000
08806195928134 K070569 000
08806195928127 K070569 000
08806195928110 K070569 000
08806195928103 K070569 000
08806195928097 K070569 000
08806195928080 K070569 000
08806195928073 K070569 000
08806195928066 K070569 000
08806195928059 K070569 000
08806195928042 K070569 000
08806195928035 K070569 000
08806195928028 K070569 000
08806195928011 K070569 000
08806195928004 K070569 000
08806195928165 K070569 000
08806195928172 K070569 000
08806195928349 K070569 000
08806195928332 K070569 000
08806195928325 K070569 000
08806195928318 K070569 000
08806195928301 K070569 000
08806195928295 K070569 000
08806195928271 K070569 000
08806195928264 K070569 000
08806195928257 K070569 000
08806195928240 K070569 000
08806195928233 K070569 000
08806195928226 K070569 000
08806195928219 K070569 000
08806195928202 K070569 000
08806195928196 K070569 000
08806195928189 K070569 000
08806195927991 K070569 000
08806195928608 K070569 000
08806195926901 K070569 000
08806195926536 K070569 000
08806195926437 K070569 000
08806195926420 K070569 000
08806195926413 K070569 000
08806195920046 K070569 000
08806195920022 K070569 000
08806195919996 K070569 000
08806195919972 K070569 000
08806195920039 K070569 000
08806195920015 K070569 000
08806195920008 K070569 000
08806195919989 K070569 000
08806195919965 K070569 000
08806195917572 K070569 000
08806195917565 K070569 000
08806195917558 K070569 000
08806195926550 K070569 000
08806195926574 K070569 000
08806195926895 K070569 000
08806195926888 K070569 000
08806195926871 K070569 000
08806195926864 K070569 000
08806195926826 K070569 000
08806195926819 K070569 000
08806195926802 K070569 000
08806195926796 K070569 000
08806195926789 K070569 000
08806195926772 K070569 000
08806195926727 K070569 000
08806195926710 K070569 000
08806195926703 K070569 000
08806195926659 K070569 000
08806195926604 K070569 000
08806195926598 K070569 000
08806195917541 K070569 000
08806195917404 K070569 000
08806195917398 K070569 000
08806195916902 K070569 000
08806195916872 K070569 000
08806195916865 K070569 000
08806195916650 K070569 000
08806195916643 K070569 000
08806195916636 K070569 000
08806195916629 K070569 000
08806195916605 K070569 000
08806195916322 K070569 000
08806195916315 K070569 000
08806195916308 K070569 000
08806195916278 K070569 000
08806195916261 K070569 000
08806195916254 K070569 000
08806195916247 K070569 000
08806195911372 K070569 000
08806195916919 K070569 000
08806195916926 K070569 000
08806195917381 K070569 000
08806195917091 K070569 000
08806195917084 K070569 000
08806195917077 K070569 000
08806195917060 K070569 000
08806195917053 K070569 000
08806195917039 K070569 000
08806195917015 K070569 000
08806195917008 K070569 000
08806195916995 K070569 000
08806195916988 K070569 000
08806195916971 K070569 000
08806195916964 K070569 000
08806195916957 K070569 000
08806195916940 K070569 000
08806195916933 K070569 000
08806195911365 K070569 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.