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

FDA 510(k)

SOLO PLUS ORTHO

K-Number: K990252 · 1999-02-25

ApplicantSybron Dental Specialties, Inc.
Decision Date1999-02-25
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLO PLUS ORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1999-02-25 under 510(k) number K990252. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLO PLUS ORTHO?

SOLO PLUS ORTHO is a medical device that received FDA 510(k) clearance on 1999-02-25. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K990252.

When did SOLO PLUS ORTHO receive FDA 510(k) clearance?

SOLO PLUS ORTHO received FDA 510(k) clearance on 1999-02-25, under 510(k) number K990252.

Who is the listed applicant for SOLO PLUS ORTHO?

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

What is the FDA product code for SOLO PLUS ORTHO?

The FDA product code for SOLO PLUS ORTHO is DYH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sybron Dental Specialties, 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.

K093341CENTURY MODEL 105CK091091SONICFILL 2010K080089SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPSK073478SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTSK071615FIXAFLOSSK071288MODIFICATION TO KAVO QUATTROCARE

View all 106 devices →

Related Devices (Code: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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.

↑