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FDA 510(k)

NEODONTICS DENTAL IMPLANT

K-Number: K821025 · 1982-08-30

ApplicantNeodontics, Inc.
Decision Date1982-08-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEODONTICS DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Neodontics, Inc.. It received FDA 510(k) clearance on 1982-08-30 under 510(k) number K821025. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEODONTICS DENTAL IMPLANT?

NEODONTICS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1982-08-30. The listed applicant is Neodontics, Inc.. The 510(k) number is K821025.

When did NEODONTICS DENTAL IMPLANT receive FDA 510(k) clearance?

NEODONTICS DENTAL IMPLANT received FDA 510(k) clearance on 1982-08-30, under 510(k) number K821025.

Who is the listed applicant for NEODONTICS DENTAL IMPLANT?

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

What is the FDA product code for NEODONTICS DENTAL IMPLANT?

The FDA product code for NEODONTICS DENTAL IMPLANT is DZE.

Related Clinical Trials

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.

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Other records listing Neodontics, 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.

K950951NEOCAST C, V, S

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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