Coltene/Whaledent, Inc.
Coltene/Whaledent, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2007, with 14 FDA device recalls on record.
Top product codes for Coltene/Whaledent, Inc.
FDA recalls by Coltene/Whaledent, Inc.
10 most recent of 14- Z-1208-2023 — SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
- Z-1494-2021 — Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
- Z-0465-2021 — FG 57 100057X (100057X)
- Z-0464-2021 — Alpen Clinic 100 Carbide Instruments (R100057C)
- Z-0468-2021 — Strauss 25 Carbide Dental Burs (100057XXV)
- Z-0466-2021 — Clinic Pack 100 Pieces FG 57 100057C (100057C)
- Z-0467-2021 — CEI Cutting Edge Instruments (PTC-57C)
- Z-2420-2020 — HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
- Z-2421-2020 — HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
- Z-2419-2020 — HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Coltene/Whaledent, Inc.
- K071632 — PERFECT TISSUE CONTOURING SYSTEM II
- K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
- K040551 — COLTOLUX LED CURING LIGHT
- K033760 — ONE COAT SE BOND
- K031752 — COLTOSOL F
- K013400 — SYNERGY FLOW
- K003034 — COLTENE AURA COMPOMER RESTORATIVE SYSTEM
- K993545 — TENAX WHITE POST
- K000311 — PARAPOST FIBER WHITE
- K993710 — MODIFICATION OF PARAPOST CEMENT
- K993835 — PARAPOST SYSTEM STERILIZABLE ORGANIZER
- K993255 — BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
- K983727 — BIOSONIC ULTRASONIC SCALER SYSTEM
- K974906 — ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
- K974465 — SYNERGY
- K945698 — COLTOLUX 3, COLTOLUX 4
- K950106 — COLTOLUX LIGHT METER
- K945366 — PARAPOST CEMENT
- K934192 — PARAPOST XT SYSTEM
- K922615 — COLTENE A.R.T. BOND
- K912485 — COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.