Recall Z-0376-2019— Coltene Whaledent Inc
Class II · Terminated
Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2018-08-21, terminated 2020-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth 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.. Reason: ParaPost Plus Titanium Posts contain stainless steel post that are a size 4.
- Recalling firm
- Coltene Whaledent Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-21
- Terminated
- 2020-04-10
- Firm location
- Cuyahoga Falls, OH, United States
Product description
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth 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.
Reason for recall
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Data sourced from openFDA. This site is unofficial and independent of the FDA.