Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Orthodontic Acrylic 2

K-Number: K163482 · 2017-05-31

ApplicantLang Dental Manufacturing Co., Inc.
Decision Date2017-05-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Orthodontic Acrylic 2 is a medical device manufactured by Lang Dental Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2017-05-31 under approval number K163482. 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 Orthodontic Acrylic 2?

Orthodontic Acrylic 2 is a medical device that received FDA 510(k) clearance on 2017-05-31. It is manufactured by Lang Dental Manufacturing Co., Inc.. The 510(k) number is K163482.

When was Orthodontic Acrylic 2 approved by the FDA?

Orthodontic Acrylic 2 received FDA 510(k) clearance on 2017-05-31, under approval number K163482.

What company makes Orthodontic Acrylic 2?

Orthodontic Acrylic 2 is manufactured by Lang Dental Manufacturing Co., Inc..

What is the FDA product code for Orthodontic Acrylic 2?

The FDA product code for Orthodontic Acrylic 2 is EBI.

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.

↑