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)

DENTRONIX MODEL 2000

K-Number: K910202 · 1991-03-13

ApplicantDentronix, Inc.
Decision Date1991-03-13
Product CodeKMH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DENTRONIX MODEL 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Dentronix, Inc.. It received FDA 510(k) clearance on 1991-03-13 under 510(k) number K910202. The device is classified under product code KMH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTRONIX MODEL 2000?

DENTRONIX MODEL 2000 is a medical device that received FDA 510(k) clearance on 1991-03-13. The listed applicant is Dentronix, Inc.. The 510(k) number is K910202.

When did DENTRONIX MODEL 2000 receive FDA 510(k) clearance?

DENTRONIX MODEL 2000 received FDA 510(k) clearance on 1991-03-13, under 510(k) number K910202.

Who is the listed applicant for DENTRONIX MODEL 2000?

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

What is the FDA product code for DENTRONIX MODEL 2000?

The FDA product code for DENTRONIX MODEL 2000 is KMH.

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 Dentronix, 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.

K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMK771005NEW PODIATRY PRODUCTSK771006MODIFIED PODIATRY PRODUCTSK770303NIPPER, NAIL, P610 ENGLISHK770305CUTTER, P607 BONEK770302CUTTER, P606 BONE

View all 9 devices →

Related Devices (Code: KMH)

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.

K094026STERI-DENT, STERI-SURECpac, Inc.K051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMColtene/Whaledent, Inc.K910925DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.K881371COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLECox Sterile Products, Inc.K872643COX RAPID HEAT TRANSFER STERILIZERCox Sterile Products, 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.

↑