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FDA 510(k)

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)

K-Number: K964619 · 1997-01-22

ApplicantSds Dental, Inc.
Decision Date1997-01-22
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) is the device name listed in this FDA 510(k) record. The listed applicant is Sds Dental, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964619. 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 DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)?

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Sds Dental, Inc.. The 510(k) number is K964619.

When did DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) receive FDA 510(k) clearance?

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964619.

Who is the listed applicant for DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)?

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

What is the FDA product code for DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)?

The FDA product code for DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) is EIA.

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Other records listing Sds Dental, 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.

K990546DELSONIC 2000K990545JETSONIC 2000K902864SURGICAL LIGHTING-CENTRA 450K902865BAUMER SURGICAL TABLEK863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-IIK863013ISOLAX PEDAL SET

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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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