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)

PRODIGY- 3

K-Number: K983370 · 1998-11-18

ApplicantSybron Dental Specialties, Inc.
Decision Date1998-11-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRODIGY- 3 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 1998-11-18 under 510(k) number K983370. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRODIGY- 3?

PRODIGY- 3 is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K983370.

When did PRODIGY- 3 receive FDA 510(k) clearance?

PRODIGY- 3 received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983370.

Who is the listed applicant for PRODIGY- 3?

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 PRODIGY- 3?

The FDA product code for PRODIGY- 3 is EBF.

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: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑