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FDA 510(k)

TOMOGRAPH ACCESSORIES

K-Number: K962120 · 1996-07-25

ApplicantSteri-Oss, Inc.
Decision Date1996-07-25
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOMOGRAPH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Steri-Oss, Inc.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K962120. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMOGRAPH ACCESSORIES?

TOMOGRAPH ACCESSORIES is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Steri-Oss, Inc.. The 510(k) number is K962120.

When did TOMOGRAPH ACCESSORIES receive FDA 510(k) clearance?

TOMOGRAPH ACCESSORIES received FDA 510(k) clearance on 1996-07-25, under 510(k) number K962120.

Who is the listed applicant for TOMOGRAPH ACCESSORIES?

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

What is the FDA product code for TOMOGRAPH ACCESSORIES?

The FDA product code for TOMOGRAPH ACCESSORIES is EHD.

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Other records listing Steri-Oss, 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.

K982400STERI-OSS' IMPROV TEMPORARY DENTAL CEMENTK980439REPLACE CYLINDRICAL IMPLANTSK973423STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANTK973433STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANTK973402STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEMK972965STERI-OSS UNTIL IMPLANT CEMENT

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Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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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