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FDA 510(k)

MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT

K-Number: K983847 · 1998-12-01

ApplicantGermiphene Corp.
Decision Date1998-12-01
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Germiphene Corp.. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K983847. 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 MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT?

MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Germiphene Corp.. The 510(k) number is K983847.

When did MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT receive FDA 510(k) clearance?

MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT received FDA 510(k) clearance on 1998-12-01, under 510(k) number K983847.

Who is the listed applicant for MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT?

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

What is the FDA product code for MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT?

The FDA product code for MODIFICATION OF: ODYSSEY I DENTAL WATER 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 Germiphene Corp. 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.

K961289VAPOPHENEK964796ODYSSEY I DENTAL WATER UNITK942851SMILE INTEGRATED PROPHYLAXIS PASTE RINGSK894933PERLIDENT

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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