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FDA 510(k)

SALIVA ABSORBER - DENTAL

K-Number: K900631 · 1990-04-04

ApplicantKab Gloves Unltd.
Decision Date1990-04-04
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SALIVA ABSORBER - DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Kab Gloves Unltd.. It received FDA 510(k) clearance on 1990-04-04 under 510(k) number K900631. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALIVA ABSORBER - DENTAL?

SALIVA ABSORBER - DENTAL is a medical device that received FDA 510(k) clearance on 1990-04-04. The listed applicant is Kab Gloves Unltd.. The 510(k) number is K900631.

When did SALIVA ABSORBER - DENTAL receive FDA 510(k) clearance?

SALIVA ABSORBER - DENTAL received FDA 510(k) clearance on 1990-04-04, under 510(k) number K900631.

Who is the listed applicant for SALIVA ABSORBER - DENTAL?

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

What is the FDA product code for SALIVA ABSORBER - DENTAL?

The FDA product code for SALIVA ABSORBER - DENTAL is DYN.

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 Kab Gloves Unltd. 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.

K900135CU-75 VISIBLE LIGHT-CURING UNITK900089FG DIAMOND BURRSK900088MASKS SURGICAL DENTAL

Related Devices (Code: DYN)

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.

K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflexK935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K921117MINIDAMDelsan Dental Systems

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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