FDA 510(k)

SMH FLEX S

K-Number: K073040 · 2007-12-13

Decision Date2007-12-13

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SMH FLEX S is the device name listed in this FDA 510(k) record. The listed applicant is Smh Biomaterial AG. It received FDA 510(k) clearance on 2007-12-13 under 510(k) number K073040. 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 SMH FLEX S?

SMH FLEX S is a medical device that received FDA 510(k) clearance on 2007-12-13. The listed applicant is Smh Biomaterial AG. The 510(k) number is K073040.

When did SMH FLEX S receive FDA 510(k) clearance?

SMH FLEX S received FDA 510(k) clearance on 2007-12-13, under 510(k) number K073040.

Who is the listed applicant for SMH FLEX S?

The FDA 510(k) record lists Smh Biomaterial AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMH FLEX S?

The FDA product code for SMH FLEX S is EBI.

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.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.

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.