Modification of Parapost Cement

Q: What is the product code of K993710?

The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.

FDA 510(k) K993710 · Coltene/Whaledent, Inc.

Substantially Equivalent

510(k) numberK993710

Submission

Device name: Modification of Parapost Cement
Applicant: Coltene/Whaledent, Inc.
Mahwah, NJ, US
Received: November 3, 1999
Decision date: December 21, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EMA – Cement, Dental
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3275
Specialty: Dental

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Questions and answers

When was Modification of Parapost Cement cleared by the FDA?

Modification of Parapost Cement (K993710) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 48 days after the submission was received.

What is the product code of K993710?

The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.