Heraeus Kulzer, LLC
Heraeus Kulzer, LLC holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2013, with 2 FDA device recalls on record.
Top product codes for Heraeus Kulzer, LLC
FDA recalls by Heraeus Kulzer, LLC
- Z-1651-2014 — Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
- Z-1133-2014 — BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
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 Heraeus Kulzer, LLC
- K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
- K123278 — IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
- K120914 — FLEXITIME FAST & SCAN LIGHT FLOW
- K113574 — FLEXITIME MONOPHASE PRO SCAN
- K112501 — VENUS PEARL PLT REFILL A1
- K111832 — PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
- K110037 — PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID
- K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW
- K101617 — FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
- K093575 — GLUMA DESENSITIZER POWER GEL
- K091635 — VENUS DIAMOND FLOW
Data sourced from openFDA. This site is unofficial and independent of the FDA.