510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170849Substantially Equivalent

SIMPLANT Guide

Dentsply Sirona Inc, York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170849 is the FDA 510(k) clearance record for SIMPLANT Guide, a class I device, cleared for Dentsply Sirona on under FDA product code NDP (Accessories, Implant, Dental, Endosseous). FDA records list 86 510(k) clearances for Dentsply Sirona, from to . As of , FDA records show no recalls naming K170849.

Clearance record

Decision date
Received
(85 days to decision)
Product code
NDP Accessories, Implant, Dental, Endosseous
Regulation
21 CFR 872.3980
Device class
Class I
Review panel
Dental
Applicant
Dentsply Sirona 221 W. Philadelphia St., York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDP

Trailing 12 months

FDA records hold no clearances under product code NDP in the trailing twelve months.

FDA records show no clearances under product code NDP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260