Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

Q: What is the product code of K200555?

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

FDA 510(k) K200555 · Prevest Denpro Limited

Substantially Equivalent

510(k) numberK200555

Submission

Device name: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
Applicant: Prevest Denpro Limited
Bari Brahmana, IN
Received: March 3, 2020
Decision date: May 13, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) cleared by the FDA?

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (K200555) received a 510(k) decision of Substantially Equivalent on May 13, 2021, 436 days after the submission was received.

What is the product code of K200555?

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