ClearanceBrief
Panels › Dental › Product code EJL · Class 1

Bur, Dental

Regulation 872.3240

0510(k)s in 12 months (27 all time)
0recalls in 12 months (13 all time)
0recalls that name a 510(k)
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Top companies in EJL

Company510(k)sRecalls
Coltene /Whaledent AG07
Almore Intl., Inc.20
Hager & Meisinger Gmbh02
Swiss American Metal Craft Corp.20
A & M Instruments, Inc.10
Adp Intl., Inc.10
Aesculap Instruments Corp.10
B.T.I. Biotechnology Institute, Sl.10
Beavers Dental, Div. Sybron Canada, Ltd.10
Biomet Microfixation, Inc.01
DateFirm and productCodeLinked 510(k)
Mar 21, 2025Premier Dental Products Co
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Open, Classified
EJLNone listed
Feb 7, 2024Brasseler USA I Lp
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Open, Classified
EJLNone listed
Oct 20, 2020Coltene Whaledent Inc
Strauss 25 Carbide Dental Burs (100057XXV)
Open, Classified
EJLNone listed
Oct 20, 2020Coltene Whaledent Inc
CEI Cutting Edge Instruments (PTC-57C)
Open, Classified
EJLNone listed
Oct 20, 2020Coltene Whaledent Inc
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Open, Classified
EJLNone listed
Oct 20, 2020Coltene Whaledent Inc
FG 57 100057X (100057X)
Open, Classified
EJLNone listed
Oct 20, 2020Coltene Whaledent Inc
Alpen Clinic 100 Carbide Instruments (R100057C)
Open, Classified
EJLNone listed
Jul 15, 2020Hager & Meisinger Gmbh
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended
Terminated
EJLNone listed
Jan 30, 2020Jjgc Industria E Comercio De Materials Dentarios Sa
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Terminated
EJLNone listed
Jul 19, 2019Coltene /Whaledent AG
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
Terminated
EJLNone listed
Nov 7, 2018Hager & Meisinger Gmbh
Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
Open, Classified
EJLNone listed
May 14, 2018Coltene Whaledent Inc
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, su
Terminated
EJLNone listed
Sep 8, 2009Biomet Microfixation, Inc.
BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
Terminated
EJLNone listed

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