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FDA 510(k)

SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM

K-Number: K884732 · 1989-05-18

ApplicantBio-Interfaces, Inc.
Decision Date1989-05-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Interfaces, Inc.. It received FDA 510(k) clearance on 1989-05-18 under 510(k) number K884732. 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 SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM?

SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-18. The listed applicant is Bio-Interfaces, Inc.. The 510(k) number is K884732.

When did SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1989-05-18, under 510(k) number K884732.

Who is the listed applicant for SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM?

The FDA product code for SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Bio-Interfaces, 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.

K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140K954763BIO-INTERFACES, INC,. BII-PLASTK950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTK950567BIO-APATITE 6140 HA PARTICLESK950511BLL-FIL 6140 PARTICLESK934049BII-PORE(TM) CANAL WALL PROSTHESIS

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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

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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