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FDA 510(k)

PREMIER ABSORBENT POINTS

K-Number: K800827 · 1980-04-29

ApplicantPremier Dental Products Co.
Decision Date1980-04-29
Product CodeEKN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER ABSORBENT POINTS is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800827. The device is classified under product code EKN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER ABSORBENT POINTS?

PREMIER ABSORBENT POINTS is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Premier Dental Products Co.. The 510(k) number is K800827.

When did PREMIER ABSORBENT POINTS receive FDA 510(k) clearance?

PREMIER ABSORBENT POINTS received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800827.

Who is the listed applicant for PREMIER ABSORBENT POINTS?

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

What is the FDA product code for PREMIER ABSORBENT POINTS?

The FDA product code for PREMIER ABSORBENT POINTS is EKN.

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Other records listing Premier Dental Products 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061998PREMIER SELF-ETCHING BOND ENHANCER

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Related Devices (Code: EKN)

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.

K843017ABSORBENT ENDODONTIC POINTUnited Dental Mfg., Inc.K821625ENDODONTIC PAPERPOINTSRoekoK812886ENDODONTIC PAPER POINTSUnited Dental Mfg., Inc.K781605R&R ABSORBENT POINTSRansom and RandolphK761203ABSORBENT POINTSJohnson & Johnson Professionals, Inc.K760983ENDODONTIC INSTRUMENTSAdp 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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