Parapost XT System
FDA 510(k) K934192 · Coltene/Whaledent, Inc.
510(k) numberK934192
Submission
- Device name
- Parapost XT System
- Applicant
- Coltene/Whaledent, Inc.
Mahwah, NJ, US - Received
- August 26, 1993
- Decision date
- June 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Parapost XT System cleared by the FDA?
Parapost XT System (K934192) received a 510(k) decision of Substantially Equivalent on June 6, 1994, 284 days after the submission was received.
What is the product code of K934192?
The FDA product code is ELR – Post, Root Canal, a Class I (low risk) device regulated under 21 CFR 872.3810.