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FDA 510(k)

HANDY IIM

K-Number: K833039 · 1983-10-04

ApplicantShofu Dental Corp.
Decision Date1983-10-04
Product CodeEJP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HANDY IIM is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K833039. The device is classified under product code EJP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDY IIM?

HANDY IIM is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Shofu Dental Corp.. The 510(k) number is K833039.

When did HANDY IIM receive FDA 510(k) clearance?

HANDY IIM received FDA 510(k) clearance on 1983-10-04, under 510(k) number K833039.

Who is the listed applicant for HANDY IIM?

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

What is the FDA product code for HANDY IIM?

The FDA product code for HANDY IIM is EJP.

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Other records listing Shofu Dental 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.

K111855HY-BOND RESIGLASSK110252BEAUTIBOND MULTI PR PLUSK110235BEAUTIBOND MULTIK101603BEAUTIFIL FLOW PLUSK101621LITE ARTK093559VINTAGE MP

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Related Devices (Code: EJP)

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.

K926190ALRAND INC. (DENTAL HAND INSTRUMENTS)Alrand, Inc.K896131GNATHOMAT ARTICULATORIvoclar North America, Inc.K892373DENTAL PLASTIC BITE FORKTexapol Corp.K884418PREMIER DIE-TRAK ARTICULATORPremier MedicalK872943DISPOSABLE ARTICULATORDentsply Intl.K863009GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEXSds Dental, Inc.

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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