510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912989Substantially Equivalent

Planustar and Dens Nobilis Denture Teeth

Wilde-USA, Inc., Naperville IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912989 is the FDA 510(k) clearance record for PLANUSTAR AND DENS NOBILIS DENTURE TEETH, a class I device, cleared for Wilde-USA, Inc. on under FDA product code EMI (File, Bone, Surgical). FDA records list 16 510(k) clearances for Wilde-USA, Inc., from to . As of , FDA records show no recalls naming K912989.

Clearance record

Decision date
Received
(39 days to decision)
Product code
EMI File, Bone, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Wilde-USA, Inc. P.O. Box 4168, Naperville IL
510(k) summary
Statement
Third party review
No

Clearances, product code EMI

Trailing 12 months

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

FDA records show no clearances under product code EMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMI, 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