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FDA 510(k)

PUMA DENTAL CHAIR AND UNIT

K-Number: K000837 · 2000-07-11

ApplicantCastellini S.P.A.
Decision Date2000-07-11
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PUMA DENTAL CHAIR AND UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Castellini S.P.A.. It received FDA 510(k) clearance on 2000-07-11 under 510(k) number K000837. 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 PUMA DENTAL CHAIR AND UNIT?

PUMA DENTAL CHAIR AND UNIT is a medical device that received FDA 510(k) clearance on 2000-07-11. The listed applicant is Castellini S.P.A.. The 510(k) number is K000837.

When did PUMA DENTAL CHAIR AND UNIT receive FDA 510(k) clearance?

PUMA DENTAL CHAIR AND UNIT received FDA 510(k) clearance on 2000-07-11, under 510(k) number K000837.

Who is the listed applicant for PUMA DENTAL CHAIR AND UNIT?

The FDA 510(k) record lists Castellini S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUMA DENTAL CHAIR AND UNIT?

The FDA product code for PUMA DENTAL CHAIR AND UNIT is EIA.

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.

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Other records listing Castellini S.P.A. 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.

K023513LOGOS JUNIOR DENTAL CHAIR AND UNITK000834CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTOK932111DENTAL X-RAY UNIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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