Product Code: DZI


Products Classified as DZI

1103Drill, Bone, PoweredBone Cutting Instrument And Accessories.

Total Product Life Cycle (TPLC) Devices

1103Drill, Bone, PoweredBone Cutting Instrument And Accessories.

FDA Consensus Standards

Drill, Bone, Powered [32309]21 CFR §872.4120 🔎
Drill, Bone, Powered [37950]21 CFR §872.4120 🔎
Drill, Bone, Powered [34709]21 CFR §872.4120 🔎
Drill, Bone, Powered [32013]21 CFR §872.4120 🔎

Pre-market Notifications for DZI

K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC
K192561TRAUS SUS20Saeshin Precision Co., Ltd.
K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad TipBennett Jacoby, DDS, MS, Inc.
K172137PIEZOTOME CUBESatelec - Acteon Group
K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron SPA
K171326Piezosurgery WhiteMectron S.p.a
K152125Oral Surgery System And AccessoriesBONART CO., LTD.
K151248PIEZOSURGERY WHITEMECTRON SPA
K151171TRAUS SUS10SAESHIN PRECISION CO., LTD.
K150076Sonic Surgeon 310L, Sonic Surgeon 600L And Sonic Surgeon 800LDONG IL TECHNOLOGY LTD.
K133488PIEZOMEDW & H DENTALWERK BUERMOOS GMBH
K122322PIEZOSURGERY TOUCHMECTRON S.P.A.
K121620ULTRASONIC SURGERYDMETEC CO., LTD.
K113152ULTRASONIC SURGERY MACHINEDMETEC CO., LTD.
K112188PIEZOTOME SOLOSATELEC - ACTEON, INC.

Global Unique Device Identification Database

07613353087524Drill, Bone, Powered
07613353087487Drill, Bone, Powered
07613353030025Drill, Bone, Powered
07613353030001Drill, Bone, Powered
07613353029982Drill, Bone, Powered
07613353029968Drill, Bone, Powered
07613353029845Drill, Bone, Powered
07613353029821Drill, Bone, Powered
07613353029814Drill, Bone, Powered
07613353029807Drill, Bone, Powered
07613353029791Drill, Bone, Powered
07613353029784Drill, Bone, Powered
07613353029777Drill, Bone, Powered
07613353002688Drill, Bone, Powered
07613353002671Drill, Bone, Powered

Maude Adverse Events

HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-06
SHAFT FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-06
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-06
SHAFT FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-06
SHAFT FOR 90? SCREWDRIVEROBERDORF SYNTHES PRODUKTIONS GMBH2020-03-03
TURNING HANDLE F/90? SCRWDRVROBERDORF SYNTHES PRODUKTIONS GMBH2020-03-03
HANDLE FOR 90? SCREWDRIVEROBERDORF SYNTHES PRODUKTIONS GMBH2020-03-03
1.1MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-10
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043OBERDORF SYNTHES PRODUKTIONS GMBH2020-01-17
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-17
STEP DRILL SHORT (6-10MML)IMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-20
SHAFTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-18
STEP DRILL (6-16MML)IMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-06
1.5MM DRILL BIT/MINI QC WITH 6MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-29
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047WRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-28
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-24
UNKNOWN - INSTRUMENT/TOOLNOBEL BIOCARE AB - KGA2019-10-24
MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044OBERDORF SYNTHES PRODUKTIONS GMBH2019-10-04
MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044OBERDORF SYNTHES PRODUKTIONS GMBH2019-10-04
SHAFT FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-02
HANDLE FOR 90? SCREWDRIVEROBERDORF SYNTHES PRODUKTIONS GMBH2019-09-19
?1.5MM DRILL BIT W/8MM STOP 15MM F/90? SCRWDRVR MTRXMANDBLOBERDORF SYNTHES PRODUKTIONS GMBH2019-08-23
?1.5MM DRILL BIT W/8MM STOP 15MM F/90? SCRWDRVR MTRXMANDBLOBERDORF SYNTHES PRODUKTIONS GMBH2019-08-23
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-08-19
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-08-19
GEAR FOR SCREWDRIVER 90?WRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-08-13
GEAR COVER FOR SCREWDRIVER 90?WRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-08-13
1.1MM DRILL BIT/STRYKER J-LTCH WITH 6MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2019-06-28
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-05-30
2.4MM DRILL BIT/QC/100MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-05-30
DRILL TAPERED 3.5X13MMNOBEL BIOCARE AB2019-05-28
1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90? SCREWDRIVEROBERDORF SYNTHES PRODUKTIONS GMBH2019-05-24
?1.5MM DRILL BIT W/6MM STOP 13MM F/90? SCRWDRVR MTRXMANDBLOBERDORF SYNTHES PRODUKTIONS GMBH2019-05-24
BROCA ?1.5 C/TRAV C13/6 2AREST-CORTOBERDORF SYNTHES PRODUKTIONS GMBH2019-05-23
?1.5MM DRILL BIT W/6MM STOP 13MM F/90? SCRWDRVR MTRXMANDBLOBERDORF SYNTHES PRODUKTIONS GMBH2019-04-02
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-04-01
1.5MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2019-03-14
PIEZOSURGERY2019-02-19
PIEZOSURGERYMECTRON S.P.A.2019-02-11
1.1MM DRILL BIT/MINI QC WITH 4MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2019-02-11
PIEZOSURGERYMECTRON S.P.A.2019-02-11
LOCATOR DRILLIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-02-08
1.5MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2019-02-07
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MMOBERDORF SYNTHES PRODUKTIONS GMBH2018-12-28
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047OBERDORF SYNTHES PRODUKTIONS GMBH2018-12-28
MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MMOBERDORF SYNTHES PRODUKTIONS GMBH2018-12-28
MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047OBERDORF SYNTHES PRODUKTIONS GMBH2018-12-27
HANDLE FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2018-12-18
SHAFT FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2018-12-18
SHAFT FOR 90? SCREWDRIVERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2018-11-27
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