510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K130198Substantially Equivalent

Neo Denta Zirconia

Neo Group Limited, Hung Hom, Kowloon, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130198 is the FDA 510(k) clearance record for NEO DENTA ZIRCONIA, a class II device, cleared for Neo Group Limited on under FDA product code EIH (Powder, Porcelain). FDA records list one 510(k) clearance for Neo Group Limited. As of , FDA records show no recalls naming K130198.

Clearance record

Decision date
Received
(266 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Neo Group Limited Rm. Q1d G/F, Kaiser Est 3rd Phase, 18 Man Lok St., Hung Hom, Kowloon, HK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIH

Trailing 12 months
13 clearances under product code EIH in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20262
April 20261
May 20261
June 20263
July 20262
August 20261
September 20260
October 20260