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AA-1110 ANALOG ABUTMENT

K903042 Class II Traditional
Decision Date
1990-11-13
Sponsor / Applicant
Minimatic Implant Technology

Technical Specification

510(k) Submission ID K903042
Product Code DZE
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3640
Decision Date 1990-11-13
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

AA-1110 ANALOG ABUTMENT received FDA 510(k) clearance under submission number K903042, sponsored by Minimatic Implant Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-11-13.

Classification & Regulation

This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.