FDA 510(k)

Pac-Dent Denture Base Resin

K-Number: K210189 · 2021-07-28

Decision Date2021-07-28

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Pac-Dent Denture Base Resin is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-07-28 under approval number K210189. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pac-Dent Denture Base Resin?

Pac-Dent Denture Base Resin is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K210189.

When was Pac-Dent Denture Base Resin approved by the FDA?

Pac-Dent Denture Base Resin received FDA 510(k) clearance on 2021-07-28, under approval number K210189.

What company makes Pac-Dent Denture Base Resin?

Pac-Dent Denture Base Resin is manufactured by Pac-Dent, Inc..

What is the FDA product code for Pac-Dent Denture Base Resin?

The FDA product code for Pac-Dent Denture Base Resin is EBI.

Other Devices by Pac-Dent, Inc.

K200330RC-Prime Root Canal Preparation Cream K202831The iMask Child's Face Mask K210412Pac-Dent Ceramic Nanohybrid Resin K210186PacBond One K201182iMask Disposable Surgical Face Mask K202674Medidenta High Speed Handpieces

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Related Devices (Code: EBI)

K161330Pour AcrylicDentsply Sirona K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc. K160498Dentivera Milling DiscDental Solutions, LLC K153590AvaDent Denture Base MaterialGlobal Dental Science K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.