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FDA 510(k)

Ultra SEP

K-Number: K210945 · 2021-07-08

ApplicantReliance Orthodontic Products, Inc.
Decision Date2021-07-08
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ultra SEP is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K210945. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultra SEP?

Ultra SEP is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K210945.

When did Ultra SEP receive FDA 510(k) clearance?

Ultra SEP received FDA 510(k) clearance on 2021-07-08, under 510(k) number K210945.

Who is the listed applicant for Ultra SEP?

The FDA 510(k) record lists Reliance Orthodontic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultra SEP?

The FDA product code for Ultra SEP is KLE.

Other records listing Reliance Orthodontic Products, 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.

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Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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