ENDOSSEOUS DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

SOUTHERN IMPLANTS, INC.

The following data is part of a premarket notification filed by Southern Implants, Inc. with the FDA for Endosseous Dental Implant System.

Pre-market Notification Details

• Device ID: K070905
• 510k Number: K070905
• Device Name: ENDOSSEOUS DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: SOUTHERN IMPLANTS, INC. 10355 B DEMOCRACY LANE Fairfax, VA 22030
• Contact: Greta M Hols
• Correspondent: Greta M Hols; SOUTHERN IMPLANTS, INC. 10355 B DEMOCRACY LANE Fairfax, VA 22030
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-04-02
• Decision Date: 2007-05-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D768PAEL500	K070905	000
D768MCL4320	K070905	000
D768MCL4317D40	K070905	000
D768MCL4317D20	K070905	000
D768MCL4310	K070905	000
D768MCL3530	K070905	000
D768MCL3520	K070905	000
D768MCL3517D30	K070905	000
D768MCL3517D20	K070905	000
D768MCL4330	K070905	000
D768MCL4340	K070905	000
D768MCL4350	K070905	000
D768PAEL430	K070905	000
D768PAEL350	K070905	000
D768MCNL5030	K070905	000
D768MCNL5020	K070905	000
D768MCNL5010	K070905	000
D768MCL5030	K070905	000
D768MCL5020	K070905	000
D768MCL5010	K070905	000
D768MCL3510	K070905	000
D768GSL200	K070905	000
D768EPCTN601KT0	K070905	000
D768EPCTN503KT0	K070905	000
D768EPCTN502KT0	K070905	000
D768EPCTN501KT0	K070905	000
D768EPCTN433KT0	K070905	000
D768EPCTN432KT0	K070905	000
D768EPCTN431KT0	K070905	000
D768EPCTN353KT0	K070905	000
D768EPCTN602KT0	K070905	000
D768EPCTN603KT0	K070905	000
D768GCEL350	K070905	000
D768GSL180	K070905	000
D768GCNL600	K070905	000
D768GCNL500	K070905	000
D768GCNL430	K070905	000
D768GCNL350	K070905	000
D768GCEL600	K070905	000
D768GCEL500	K070905	000
D768GCEL430	K070905	000
D768EPCTN352KT0	K070905	000
06009544007401	K070905	000
06009544002505	K070905	000
06009544002499	K070905	000
06009544002482	K070905	000
06009544002475	K070905	000
06009544002284	K070905	000
06009544002277	K070905	000
D768TSL200	K070905	000
D768TSL180	K070905	000
06009544002598	K070905	000
06009544002604	K070905	000
06009544002611	K070905	000
06009544007395	K070905	000
06009544007388	K070905	000
06009544007371	K070905	000
06009544002925	K070905	000
06009544002918	K070905	000
06009544002901	K070905	000
06009544002895	K070905	000
06009544002628	K070905	000
D768TCAEL600	K070905	000
D768TCAEL500	K070905	000
D768PANL430	K070905	000
D768PANL350	K070905	000
D768PAMC600	K070905	000
D768PAMC480	K070905	000
D768PAL20G0	K070905	000
D768PAL200	K070905	000
D768PAL18G0	K070905	000
D768PAL180	K070905	000
D768PANL500	K070905	000
D768PANL600	K070905	000
D768TCA12EL350	K070905	000
D768TCAEL430	K070905	000
D768TCAEL350	K070905	000
D768TCA24EL500	K070905	000
D768TCA24EL430	K070905	000
D768TCA24EL350	K070905	000
D768TCA12EL600	K070905	000
D768TCA12EL500	K070905	000
D768TCA12EL430	K070905	000
D768PAEL600	K070905	000
D768HAL60W30	K070905	000
D768HAL35W50	K070905	000
D768HAL35W30	K070905	000
D768HAL3570	K070905	000
06009544018360	K070905	000
06009544018353	K070905	000
06009544018346	K070905	000
06009544018339	K070905	000
06009544018322	K070905	000
D768HAL4330	K070905	000
D768HAL4350	K070905	000
D768HAL4370	K070905	000
D768HAL6050	K070905	000
D768HAL6030	K070905	000
D768HAL50W50	K070905	000
D768HAL50W30	K070905	000
D768HAL5050	K070905	000
D768HAL5030	K070905	000
D768HAL43W50	K070905	000
D768HAL43W30	K070905	000
06009544018315	K070905	000
06009544018308	K070905	000
06009544022855	K070905	000
06009544022848	K070905	000
06009544022831	K070905	000
06009544022824	K070905	000
06009544008385	K070905	000
06009544038924	K070905	000
06009544038917	K070905	000
06009544038900	K070905	000
06009544035428	K070905	000
06009544035435	K070905	000
06009544035442	K070905	000
06009544018292	K070905	000
06009544018285	K070905	000
06009544018278	K070905	000
06009544018261	K070905	000
06009544018254	K070905	000
06009544018087	K070905	000
06009544035466	K070905	000
06009544035459	K070905	000
06009544038894	K070905	000
D768EPCTN351KT0	K070905	000
D768PAEL35P0	K070905	000
D768IALH6080	K070905	000
D768IALH60160	K070905	000
D768IALH60130	K070905	000
D768IALH601150	K070905	000
D768IALH60100	K070905	000
D768IALH5080	K070905	000
D768IALH50160	K070905	000
D768PAMC14S0	K070905	000
D768PANL35P0	K070905	000
D768PANL43P0	K070905	000
D768TCNL6010	K070905	000
D768TCNL5010	K070905	000
D768TCNL4310	K070905	000
D768TCNL3510	K070905	000
D768TCEL6010	K070905	000
D768TCEL5010	K070905	000
D768TCEL4310	K070905	000
D768TCEL3510	K070905	000
D768IALH50130	K070905	000
D768IALH501150	K070905	000
D768HMCW60	K070905	000
D768HMCW40	K070905	000
D768HMCTW960	K070905	000
D768HMCTW940	K070905	000
D768HMCT760	K070905	000
D768HMCT740	K070905	000
D768HMC60	K070905	000
D768HMC40	K070905	000
D768IALH35100	K070905	000
D768IALH351150	K070905	000
D768IALH35130	K070905	000
D768IALH50100	K070905	000
D768IALH4380	K070905	000
D768IALH43160	K070905	000
D768IALH43130	K070905	000
D768IALH431150	K070905	000
D768IALH43100	K070905	000
D768IALH3580	K070905	000
D768IALH35160	K070905	000
D768HAL60W50	K070905	000
06009544007500	K070905	000
06009544021520	K070905	000
06009544017998	K070905	000
06009544017981	K070905	000
06009544017974	K070905	000
06009544017967	K070905	000
06009544017950	K070905	000
06009544017943	K070905	000
06009544017936	K070905	000
06009544017929	K070905	000
06009544018001	K070905	000
06009544018018	K070905	000
06009544021353	K070905	000
06009544021513	K070905	000
06009544021469	K070905	000
06009544021452	K070905	000
06009544021445	K070905	000
06009544021438	K070905	000
06009544021384	K070905	000
06009544021377	K070905	000
06009544021360	K070905	000
06009544017912	K070905	000
06009544017905	K070905	000
06009544016571	K070905	000
06009544016564	K070905	000
06009544016557	K070905	000
06009544016540	K070905	000
06009544016533	K070905	000
06009544016526	K070905	000
06009544016519	K070905	000
06009544016502	K070905	000
06009544016588	K070905	000
06009544016595	K070905	000
06009544016601	K070905	000
06009544016731	K070905	000
06009544016724	K070905	000
06009544016717	K070905	000
06009544016656	K070905	000
06009544016649	K070905	000
06009544016632	K070905	000
06009544016625	K070905	000
06009544016618	K070905	000
06009544016496	K070905	000
06009544032021	K070905	000
06009544030966	K070905	000
06009544030959	K070905	000
06009544030744	K070905	000
06009544030737	K070905	000
06009544030720	K070905	000
06009544030713	K070905	000
06009544030690	K070905	000
06009544030652	K070905	000
06009544030973	K070905	000
06009544030980	K070905	000
06009544030997	K070905	000
06009544032014	K070905	000
06009544031093	K070905	000
06009544031086	K070905	000
06009544031079	K070905	000
06009544031048	K070905	000
06009544031031	K070905	000
06009544031017	K070905	000
06009544031000	K070905	000
06009544028765	K070905	000
06009544028758	K070905	000
06009544021841	K070905	000
06009544021834	K070905	000
06009544021827	K070905	000
06009544021810	K070905	000
06009544021803	K070905	000
06009544021797	K070905	000
06009544021780	K070905	000
06009544021544	K070905	000
06009544021919	K070905	000
06009544021926	K070905	000
06009544021933	K070905	000
06009544025603	K070905	000
06009544025597	K070905	000
06009544025580	K070905	000
06009544025573	K070905	000
06009544021971	K070905	000
06009544021964	K070905	000
06009544021957	K070905	000
06009544021940	K070905	000
06009544021537	K070905	000
06009544009467	K070905	000
06009544009290	K070905	000
06009544009283	K070905	000
06009544009276	K070905	000
06009544009153	K070905	000
06009544009146	K070905	000
06009544009139	K070905	000
06009544009122	K070905	000
06009544008996	K070905	000
06009544009306	K070905	000
06009544009337	K070905	000
06009544009344	K070905	000
06009544009450	K070905	000
06009544009443	K070905	000
06009544009436	K070905	000
06009544009429	K070905	000
06009544009412	K070905	000
06009544009405	K070905	000
06009544009399	K070905	000
06009544009382	K070905	000
06009544008989	K070905	000
06009544008972	K070905	000
06009544008859	K070905	000
06009544008842	K070905	000
06009544008644	K070905	000
06009544008637	K070905	000
06009544008408	K070905	000
06009544008392	K070905	000
06009544007531	K070905	000
06009544007524	K070905	000
06009544008866	K070905	000
06009544008873	K070905	000
06009544008880	K070905	000
06009544008965	K070905	000
06009544008958	K070905	000
06009544008941	K070905	000
06009544008934	K070905	000
06009544008927	K070905	000
06009544008910	K070905	000
06009544008903	K070905	000
06009544008897	K070905	000
06009544007517	K070905	000
06009544015666	K070905	000
06009544015543	K070905	000
06009544015536	K070905	000
06009544015529	K070905	000
06009544015512	K070905	000
06009544009726	K070905	000
06009544009719	K070905	000
06009544009702	K070905	000
06009544009696	K070905	000
06009544015550	K070905	000
06009544015567	K070905	000
06009544015574	K070905	000
06009544015659	K070905	000
06009544015642	K070905	000
06009544015635	K070905	000
06009544015628	K070905	000
06009544015611	K070905	000
06009544015604	K070905	000
06009544015598	K070905	000
06009544015581	K070905	000
06009544009689	K070905	000
06009544009672	K070905	000
06009544009559	K070905	000
06009544009542	K070905	000
06009544009535	K070905	000
06009544009528	K070905	000
06009544009511	K070905	000
06009544009504	K070905	000
06009544009498	K070905	000
06009544009481	K070905	000
06009544009566	K070905	000
06009544009573	K070905	000
06009544009580	K070905	000
06009544009665	K070905	000
06009544009658	K070905	000
06009544009641	K070905	000
06009544009634	K070905	000
06009544009627	K070905	000
06009544009610	K070905	000
06009544009603	K070905	000
06009544009597	K070905	000
06009544009474	K070905	000