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FDA 510(k)

BALANCE ARTICULATOR

K-Number: K811075 · 1981-05-13

ApplicantAlmore Intl., Inc.
Decision Date1981-05-13
Product CodeEJP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BALANCE ARTICULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Almore Intl., Inc.. It received FDA 510(k) clearance on 1981-05-13 under 510(k) number K811075. 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 BALANCE ARTICULATOR?

BALANCE ARTICULATOR is a medical device that received FDA 510(k) clearance on 1981-05-13. The listed applicant is Almore Intl., Inc.. The 510(k) number is K811075.

When did BALANCE ARTICULATOR receive FDA 510(k) clearance?

BALANCE ARTICULATOR received FDA 510(k) clearance on 1981-05-13, under 510(k) number K811075.

Who is the listed applicant for BALANCE ARTICULATOR?

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

What is the FDA product code for BALANCE ARTICULATOR?

The FDA product code for BALANCE ARTICULATOR is EJP.

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Other records listing Almore Intl., 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.

K862851ALMORE FACE MASKK854692MONARCH II BLEACHING INSTRUMENTK854696OP II VISIBLE LIGHT CURING SYSTEMK854691DIAMOND BURS-HANDPIECEK854690DIAMONDS BURS-COMPOSIT FINISHINGK854700EZ-ON TUBING CONDITIONER (LUBRICANT)

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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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