Name: Predicase
Price: 199 USD

K-number	K143492
Device name	OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
Applicant	Bien-Air Surgery SA
Product code	ERL
Device class	Class II
Decision date	Mar 4, 2015
Decision	Substantially Equivalent
Regulation	874.4250

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece

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