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FDA 510(k)

ENDODONTIC PAPERPOINTS

K-Number: K821625 · 1982-06-14

ApplicantRoeko
Decision Date1982-06-14
Product CodeEKN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC PAPERPOINTS is the device name listed in this FDA 510(k) record. The listed applicant is Roeko. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821625. 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 ENDODONTIC PAPERPOINTS?

ENDODONTIC PAPERPOINTS is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Roeko. The 510(k) number is K821625.

When did ENDODONTIC PAPERPOINTS receive FDA 510(k) clearance?

ENDODONTIC PAPERPOINTS received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821625.

Who is the listed applicant for ENDODONTIC PAPERPOINTS?

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

What is the FDA product code for ENDODONTIC PAPERPOINTS?

The FDA product code for ENDODONTIC PAPERPOINTS is EKN.

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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.K812886ENDODONTIC PAPER POINTSUnited Dental Mfg., Inc.K800827PREMIER ABSORBENT POINTSPremier Dental Products Co.K781605R&R ABSORBENT POINTSRansom and RandolphK761203ABSORBENT POINTSJohnson & Johnson Professionals, Inc.K760983ENDODONTIC INSTRUMENTSAdp Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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