MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011

Handpiece, Air-powered, Dental

MK-DENT GMBH

The following data is part of a premarket notification filed by Mk-dent Gmbh with the FDA for Mk-dent Low Speed Handpieces And Accessories Including Spare Parts, Tubings, And Light Power System, Models: Ls2011.

Pre-market Notification Details

• Device ID: K051872
• 510k Number: K051872
• Device Name: MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
• Classification: Handpiece, Air-powered, Dental
• Applicant: MK-DENT GMBH EISENHUTWEG 15 Kumhausen-preisenberg, DE 84036
• Contact: Martina Gunderoth
• Correspondent: Martina Gunderoth; MK-DENT GMBH EISENHUTWEG 15 Kumhausen-preisenberg, DE 84036
• Product Code: EFB
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-11
• Decision Date: 2005-10-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E490LE54L1	K051872	000
E490LPH211	K051872	000
LCH211	K051872	000
00810113691152	K051872	000
00810113691145	K051872	000
00810113691015	K051872	000
00810113691022	K051872	000
00810113691077	K051872	000
00810113691084	K051872	000
00810113691091	K051872	000
00810113691107	K051872	000
E490LPH161	K051872	000
E490LPH111	K051872	000
E490LE54LP1	K051872	000
E490LE54P1	K051872	000
E490LE741	K051872	000
E490LE74L1	K051872	000
E490LP01L1	K051872	000
E490LP11L1	K051872	000
E490LP15L1	K051872	000
E490LP27L1	K051872	000
E490LP54L1	K051872	000
E490LP74L1	K051872	000
00810113691114	K051872	000
00810113691121	K051872	000
00810113690346	K051872	000
00810113690353	K051872	000
00810113690360	K051872	000
00810113690377	K051872	000
00810113690384	K051872	000
00810113690391	K051872	000
00810113690407	K051872	000
00810113690414	K051872	000
00810113690421	K051872	000
00810113690438	K051872	000
00810113690308	K051872	000
00810113690292	K051872	000
00810113691138	K051872	000
00810113690209	K051872	000
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00810113690223	K051872	000
00810113690230	K051872	000
00810113690247	K051872	000
00810113690254	K051872	000
00810113690261	K051872	000
00810113690278	K051872	000
00810113690285	K051872	000
00810113690445	K051872	000
E490LE541	K051872	000
E490LCH211	K051872	000
E490LB1111C1	K051872	000
E490LB11W1	K051872	000
E490LB41111	K051872	000
E490LB4111P1	K051872	000
E490LBH111	K051872	000
E490LBH11C1	K051872	000
E490LBH11P1	K051872	000
E490LC011	K051872	000
E490LC01L1	K051872	000
E490LC111	K051872	000
E490LB11111	K051872	000
E490LB021	K051872	000
E490AM00021	K051872	000
E490AM00041	K051872	000
E490AM00121	K051872	000
E490AM00141	K051872	000
E490AM10021	K051872	000
E490AM10041	K051872	000
E490AM10061	K051872	000
E490AM11161	K051872	000
E490LB011	K051872	000
E490LB01W1	K051872	000
E490LC11L1	K051872	000
E490LC271	K051872	000
E490LE148LP1	K051872	000
E490LE148P1	K051872	000
E490LE151	K051872	000
E490LE15L1	K051872	000
E490LE161	K051872	000
E490LE16L1	K051872	000
E490LE211	K051872	000
E490LE21L1	K051872	000
E490LE21P1	K051872	000
E490LE271	K051872	000
E490LE148L1	K051872	000
E490LE1481	K051872	000
E490LC27L1	K051872	000
E490LC741	K051872	000
E490LC74L1	K051872	000
E490LCH111	K051872	000
E490LCH161	K051872	000
E490LCH21P1	K051872	000
E490LE011	K051872	000
E490LE01L1	K051872	000
E490LE111	K051872	000
E490LE11L1	K051872	000
E490LE27L1	K051872	000
D884AM0004	K051872	000
04050546002767	K051872	000
04050546002774	K051872	000
04050546002781	K051872	000
04050546002798	K051872	000
04050546002804	K051872	000
04050546002828	K051872	000
04050546002835	K051872	000
04050546002842	K051872	000
04050546002859	K051872	000
04050546002903	K051872	000
04050546002750	K051872	000
04050546002743	K051872	000
D884HB23K000	K051872	000
D884HB23KL000	K051872	000
D884HE21KL000	K051872	000
D884HE22KL000	K051872	000
04050546002682	K051872	000
04050546002699	K051872	000
04050546002705	K051872	000
04050546002712	K051872	000
04050546002729	K051872	000
04050546002736	K051872	000
04050546002910	K051872	000
04050546002927	K051872	000
04050546003061	K051872	000
04050546003078	K051872	000
04050546003085	K051872	000
04050546003092	K051872	000
04050546003108	K051872	000
04050546003115	K051872	000
04050546003122	K051872	000
04050546003139	K051872	000
04050546003146	K051872	000
04050546003153	K051872	000
04050546003054	K051872	000
04050546003047	K051872	000
04050546002934	K051872	000
04050546002958	K051872	000
04050546002965	K051872	000
04050546002972	K051872	000
04050546002989	K051872	000
04050546002996	K051872	000
04050546003009	K051872	000
04050546003016	K051872	000
04050546003023	K051872	000
04050546003030	K051872	000
04050546003160	K051872	000
00810113690940	K051872	000
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00810113690766	K051872	000
00810113690773	K051872	000
00810113690780	K051872	000
00810113690797	K051872	000
00810113690933	K051872	000