8 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Strauss 25 Carbide Dental Burs (100057XXV)
FDA Enforcement
Class II
·Ongoing·Coltene Whaledent Inc·November 25, 2020
DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F
FDA Enforcement
Class II
·Terminated·Coltene /Whaledent AG·September 11, 2019
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
FDA Enforcement
Class II
·Ongoing·Brasseler USA I Lp·February 14, 2024
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·June 18, 2014
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
FDA Enforcement
Class II
·Terminated·Jjgc Industria E Comercio De Materials Dentarios Sa·February 12, 2020
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
FDA Enforcement
Class II
·Terminated·Keystone Dental Inc·May 2, 2018