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FDA 510(k)

DENTIX DENTAL X-RAY UNIT

K-Number: K792307 · 1980-01-09

ApplicantPrecise Optics
Decision Date1980-01-09
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIX DENTAL X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics. It received FDA 510(k) clearance on 1980-01-09 under 510(k) number K792307. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTIX DENTAL X-RAY UNIT?

DENTIX DENTAL X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is Precise Optics. The 510(k) number is K792307.

When did DENTIX DENTAL X-RAY UNIT receive FDA 510(k) clearance?

DENTIX DENTAL X-RAY UNIT received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792307.

Who is the listed applicant for DENTIX DENTAL X-RAY UNIT?

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

What is the FDA product code for DENTIX DENTAL X-RAY UNIT?

The FDA product code for DENTIX DENTAL X-RAY UNIT is EAP.

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 Precise Optics 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.

K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMK935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERK932878PRECISION INTRA-ORAL SCOPESK914084ENDOSCOPESK914184P2020-8-0 BEAM-LIMITING DEVICEK911744PRECISION OPTICS CORPORATION LAPAROSCOPE

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Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, 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.

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