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510(k) K083569

SURGYBONE by Silfradent S.R.L. — Product Code DZI

K083569 is an FDA 510(k) premarket notification submitted by Silfradent S.R.L. for the device "SURGYBONE". The FDA issued a decision of Substantially Equivalent on Apr 1, 2009. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 1, 2009
Date Received
Dec 3, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type
510(k)

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  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour… (Jun 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)

FDA data resources

Source: FDA 510(k) database entry for K083569. Report a data issue: hello@regdatalab.com.