510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K130216Substantially Equivalent

Atlantis Straumann Bone Level Abutment

Dentsply Implant, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130216 is the FDA 510(k) clearance record for ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, a class II device, cleared for Dentsply Implant on under FDA product code NHA (Abutment, Implant, Dental, Endosseous). FDA's definition for product code NHA reads: "To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation". FDA records list one 510(k) clearance for Dentsply Implant. As of , FDA records show no recalls naming K130216.

Clearance record

Decision date
Received
(92 days to decision)
Product code
NHA Abutment, Implant, Dental, Endosseous
Regulation
21 CFR 872.3630
Device class
Class II
Review panel
Dental
Applicant
Dentsply Implant 12264 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHA

Trailing 12 months
30 clearances under product code NHA in the twelve months to October 2026, June 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code NHA, trailing twelve months
MonthClearances
November 20253
December 20254
January 20265
February 20261
March 20261
April 20262
May 20263
June 20266
July 20261
August 20261
September 20263
October 20260