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FDA 510(k)

STARDENTAL AXCS STERILE WATER SYSTEM

K-Number: K990844 · 1999-05-28

ApplicantDentalez Group
Decision Date1999-05-28
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STARDENTAL AXCS STERILE WATER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez Group. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K990844. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARDENTAL AXCS STERILE WATER SYSTEM?

STARDENTAL AXCS STERILE WATER SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Dentalez Group. The 510(k) number is K990844.

When did STARDENTAL AXCS STERILE WATER SYSTEM receive FDA 510(k) clearance?

STARDENTAL AXCS STERILE WATER SYSTEM received FDA 510(k) clearance on 1999-05-28, under 510(k) number K990844.

Who is the listed applicant for STARDENTAL AXCS STERILE WATER SYSTEM?

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

What is the FDA product code for STARDENTAL AXCS STERILE WATER SYSTEM?

The FDA product code for STARDENTAL AXCS STERILE WATER SYSTEM is EIA.

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Other records listing Dentalez Group 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.

K030133SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECEK021378PORTABLE HDX INTRAORAL X-RAYK983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSK982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEK960719STAR DENTAL 430 SERIES HIGH SPEED HANDPIECEK960260STAR TITAN SERIES MOTORS & ATTACHMENTS

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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