Zenostar MT, Zenostar Color Liquids— 510(k) K152118

Clearance details

Applicant

Wieland Dental + Technik GmbH & Co. KG

Product code

Code EIH

Device class

Class 2

Regulation

21 CFR 872.6660

Advisory panel

Dental

Date received

2015-07-30

Decision date

2015-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pfozheim, DE

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• Z-0017-2017 — Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0018-2017 — Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0019-2017 — Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0020-2017 — Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0021-2017 — Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0022-2017 — Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0023-2017 — Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0024-2017 — Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0025-2017 — Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0026-2017 — Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0027-2017 — Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0028-2017 — Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0029-2017 — Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0030-2017 — Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0031-2017 — Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0032-2017 — Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0033-2017 — Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0034-2017 — Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0035-2017 — Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527
• Z-0036-2017 — Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelainClass II·Terminated·Ivoclar Vivadent, Inc.·20160527

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152118.