Coltene/Whaledent AG
Coltene/Whaledent AG holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2019, with 1 FDA device recall on record.
Top product codes for Coltene/Whaledent AG
FDA recalls by Coltene/Whaledent AG
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 AG
- K191385 — BRILLIANT COMPONEER
- K190597 — BRILLIANT EverGlow Flow
- K181500 — BRILLIANT Crios
- K160800 — DuoCem
- K152927 — BRILLIANT EVERGLOW
- K152243 — One Coat 7 Universal
- K150218 — Fill-Up!
- K121621 — SOLOCEM
- K112168 — COMPONEER
- K083304 — TEMPOSIL 2
- K072604 — DUO TEMP
- K052820 — PARAPOST PARACORE AUTOMIX 5ML
- K053040 — PARACEM UNIVERSAL DC
- K051243 — JET BLUE BITE
- K050426 — TEMPOSIL, MODEL 6720
- K050013 — RETRACTOFOAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.