510(k) K152118 ยท EIH Powder, Porcelain
Zenostar MT, Zenostar Color Liquids
| Applicant | Wieland Dental + Technik GmbH & Co. KG, Pfozheim, DE |
| Decision | Substantially Equivalent, Dec 16, 2015 |
| Received | Jul 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse blue, Art. no. 681165
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse brown, art. no. 681169
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse grey, art. no. 681167
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse violet, art. no. 681166
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A1 60ml, art. no. 681050,
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A2 60ml, art. no. 681051.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A3 60ml, art. no. 681052.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A3.5 60ml, art. no. 681053.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A4 60ml, art. no. 681054.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B1 60ml, art. no. 681055.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B2 60ml, art. no. 681056.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B3 60ml, art. no. 681057.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B4 60ml, art. no. 681058.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C1 60ml, art. no. 681059.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C2 60ml art. no. 681060.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C3 60ml, art. no. 681061.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C4 60ml, art. no. 681062.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color D2 60ml, art. no. 681063.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color D3 60ml, art. no. 681064.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color D4 60ml, art. no. 681065.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse orange, art. no. 681168.
Product Usage:
For coloring dental porcelain Terminated |
EIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.