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510(k) K061383

Device
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
Applicant
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
510(k) number
K061383
Product code
EJL  
Decision
Substantially Equivalent (SESE)
Decision date
2006-08-03
Date received
2006-05-18
Regulation
872.3240
Classification name
Bur, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LEYRE Z HERNANDO
Address
Parque Tecnologico De Alava Leonardo Da Vinci 14b Minano(Alava) ES 01510 01510

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EJL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080687SMARTBURSS.S. White Burs, Inc.2008-06-20
K071352CERADRILLGebr. Brasseler GmbH & Co. KG2007-06-29
K943273TRI HAWK BUR, FG BURTri Hawk Corp.1994-08-01
K926205MONOSTERYLUtensili Super Abrasivi1994-02-10
K923883DENTAL OR SURGICAL BURStratum Dental Technologies, Inc.1993-07-27
K921406SILICONT BUR BLOCKInnovators, Inc.1992-04-28
K920243SMART BURS TOTAL CARBIDESVermont Diamond Instruments1992-03-25
K911208TIN COATED DENTAL BURSSurgical Precision Instruments, Corp.1991-09-16
K910794SMALL INSTRUMENT STERILIZATION/BUR BOXBrevet, Inc.1991-05-23
K882183DENTAL BURSTri-Stage, Inc.1988-06-21
K873698STERILIZED DENTAL BIT PACKAGINGFlorida Diamond Instruments Corp.1987-12-03
K863097CB BURBeavers Dental, Div. Sybron Canada, Ltd.1986-08-26
K854690DIAMONDS BURS-COMPOSIT FINISHINGAlmore Intl., Inc.1986-03-25
K854691DIAMOND BURS-HANDPIECEAlmore Intl., Inc.1986-03-25
K842720BUR, DENTAL GUTTA PERCHA-FILE-PULP CANALPenn-Med Technology, Inc.1985-05-21

Legacy Summary#

summary

FDA Review#

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