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FDA 510(k)

MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL

K-Number: K791326 · 1979-10-17

ApplicantSherwood Medical Co.
Decision Date1979-10-17
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791326. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL?

MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Sherwood Medical Co.. The 510(k) number is K791326.

When did MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL receive FDA 510(k) clearance?

MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791326.

Who is the listed applicant for MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL?

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

What is the FDA product code for MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL?

The FDA product code for MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL is DZI.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, 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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