Name: Predicase
Price: 199 USD

K-number	K251205
Device name	Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants
Applicant	Dentsply Sirona
Product code	NHA
Device class	Class II
Decision date	Nov 21, 2025
Decision	Substantially Equivalent
Regulation	872.3630

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants

Everything you need for a 510(k) submission. Nothing you don't.