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)
Top companies in EJL
| Company | 510(k)s | Recalls |
|---|---|---|
| Coltene /Whaledent AG | 0 | 7 |
| Almore Intl., Inc. | 2 | 0 |
| Hager & Meisinger Gmbh | 0 | 2 |
| Swiss American Metal Craft Corp. | 2 | 0 |
| A & M Instruments, Inc. | 1 | 0 |
| Adp Intl., Inc. | 1 | 0 |
| Aesculap Instruments Corp. | 1 | 0 |
| B.T.I. Biotechnology Institute, Sl. | 1 | 0 |
| Beavers Dental, Div. Sybron Canada, Ltd. | 1 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2025 | Premier Dental Products Co Premier Solo Diamond - Large Invented Cone; SKU: 807016C. Open, Classified |
EJL | None listed |
| Feb 7, 2024 | Brasseler 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 |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc Strauss 25 Carbide
Dental Burs
(100057XXV) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc CEI Cutting Edge
Instruments (PTC-57C) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc Clinic Pack 100
Pieces FG 57
100057C (100057C) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc FG 57 100057X (100057X) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc Alpen Clinic 100 Carbide Instruments (R100057C) Open, Classified |
EJL | None listed |
| Jul 15, 2020 | Hager & 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 |
EJL | None listed |
| Jan 30, 2020 | Jjgc 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 |
EJL | None listed |
| Jul 19, 2019 | Coltene /Whaledent AG DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F Terminated |
EJL | None listed |
| Nov 7, 2018 | Hager & 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 |
EJL | None listed |
| May 14, 2018 | Coltene 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 |
EJL | None listed |
| Sep 8, 2009 | Biomet 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 |
EJL | None listed |
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