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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 the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) 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. The listed applicant is Lang Dental Manufacturing Co., Inc.. The 510(k) number is K163482.

When did Orthodontic Acrylic 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Orthodontic Acrylic 2?

The FDA 510(k) record lists Lang Dental Manufacturing Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthodontic Acrylic 2?

The FDA product code for Orthodontic Acrylic 2 is EBI.

Other records listing Lang Dental Manufacturing Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152981JET SET 4 DENTURE REPAIR RESIN

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

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

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