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FDA 510(k)

GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX

K-Number: K863009 · 1986-09-25

ApplicantSds Dental, Inc.
Decision Date1986-09-25
Product CodeEJP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX 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 1986-09-25 under 510(k) number K863009. 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 GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX?

GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX is a medical device that received FDA 510(k) clearance on 1986-09-25. The listed applicant is Sds Dental, Inc.. The 510(k) number is K863009.

When did GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX receive FDA 510(k) clearance?

GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX received FDA 510(k) clearance on 1986-09-25, under 510(k) number K863009.

Who is the listed applicant for GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX?

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 GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX?

The FDA product code for GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX is EJP.

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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 2000K964619DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)K902865BAUMER SURGICAL TABLEK902864SURGICAL LIGHTING-CENTRA 450K863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II

View all 21 devices →

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.K854702PLASTIC MOUNTING RINGSAlmore Intl., 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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