510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000680Substantially Equivalent

Vision Esthetic Porcelain System

Midatlantic Division of Dentrex, Inc., Cherry Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000680 is the FDA 510(k) clearance record for VISION ESTHETIC PORCELAIN SYSTEM, a class II device, cleared for Midatlantic Division of Dentrex, Inc. on under FDA product code EIH (Powder, Porcelain). FDA records list one 510(k) clearance for Midatlantic Division of Dentrex, Inc. As of , FDA records show no recalls naming K000680.

Clearance record

Decision date
Received
(86 days to decision)
Product code
EIH Powder, Porcelain
Regulation
21 CFR 872.6660
Device class
Class II
Review panel
Dental
Applicant
Midatlantic Division of Dentrex, Inc. 600 Deer Rd., Cherry Hill NJ
510(k) summary
Statement
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