510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161989Substantially Equivalent

PREMIUM Implant Systems SHELTA Implant Systems

Sweden & Martina Inc, Due Carrare, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161989 is the FDA 510(k) clearance record for PREMIUM Implant Systems SHELTA Implant Systems, a class II device, cleared for Sweden & Martina S.P.A. 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 8 510(k) clearances for Sweden & Martina S.P.A., from to . As of , FDA records show no recalls naming K161989.

Clearance record

Decision date
Received
(562 days to decision)
Product code
NHA Abutment, Implant, Dental, Endosseous
Regulation
21 CFR 872.3630
Device class
Class II
Review panel
Dental
Applicant
Sweden & Martina S.P.A. Via Veneto, 10, Due Carrare, IT
510(k) summary
Statement
Third party review
No

Clearances, product code NHA

Trailing 12 months
29 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 20262
October 20260