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510(k) K211804

3Delta Crown by Deltamed GmbH — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2021
Date Received
June 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K200039 — P pro Crown & Bridge (July 31, 2020)
  • K102776 — EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM (February 18, 2011)

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