Ivoclar Vivadent, Inc.
Ivoclar Vivadent, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 34 FDA device recalls on record.
Top product codes for Ivoclar Vivadent, Inc.
FDA recalls by Ivoclar Vivadent, Inc.
10 most recent of 34- Z-1006-2024 — Article No. NA6050411, Valiant PhD No. 1 Econo
- Z-0665-2018 — Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
- Z-0668-2018 — Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
- Z-0667-2018 — Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
- Z-0666-2018 — Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
- Z-0719-2017 — Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
- Z-0718-2017 — Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
- Z-0717-2017 — Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
- Z-2373-2016 — OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
- Z-0018-2017 — Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ivoclar Vivadent, Inc.
- K261485 — Tetric plus Fill; Tetric plus Flow
- K253953 — IPS e.max Zirconia
- K252450 — Adhese 2
- K233995 — Ivotion Base Print
- K153753 — TelioCAD Multi
- K143575 — Accu-Dent XD Tray, Accu-Dent XD Syringe
- K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
- K111958 — TETRIC EVOCERAM BULK FILL
- K110756 — BLUEPHASE STYLE
- K103556 — IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
- K103528 — IPS EMPRESS DIRECT FLOW
- K103391 — IVOBASE HYBRID, IVOBASE HIGH IMPACT
- K103379 — TELIO CS INLAY & TELIO CS ONLAY
- K093708 — TELIO CAD
- K093744 — EXCITE F AND EXCITE DSC
- K093331 — SR PHONARES NHC
- K090941 — ADHESE ONE F
- K090704 — MULTILINK IMPLANT
- K091020 — BLUEPHASE 20I
- K091019 — SPEEDCEM
- K090826 — MONOBOND PLUS
- K090701 — EMPRESS DIRECT
- K072338 — CERVITEC PLUS
- K071848 — IPS INLINE POM SYSTEM
- K070646 — ADHESE ONE
- K062258 — GENESIS DIODE LASER
- K062713 — ADHESIVE DC ACTIVATOR
- K061781 — MULTILINK SPRINT
- K060891 — VIRTUAL
- K060565 — CONDYLAFORM II NFC
- K060365 — APEXCAL
- K051705 — IPS E.MAX CAD/IPS E.MAX ZIRCAD
- K051782 — BLUEPHASE 16I
- K050453 — ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
- K042846 — SYSTEMP.LINK
- K042847 — SYSTEMP.CEM
- K042820 — SYSTEMP.C&B PLUS
- K042848 — FRC POSTEC PLUS
- K042819 — TETRIC EVOCERAM
- K041433 — BRIGHT GOLD XH
- K040951 — SR ADORO
- K040795 — MULTICORE HB; MULTICORE FLOW
- K033520 — BLUEPHASE
- K032470 — MULTILINK
- K030922 — VIVASENS
- K032715 — DW 296 #15 SOLDER
- K032493 — ALEXANDER
- K030435 — BIOUNIVERSAL PKF
- K030436 — BIO UNIVERSAL
- K024094 — 4 SEASONS
- K023035 — SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
- K022969 — UNIVERSAL CERAMIC SOLDER
- K022811 — W-5
- K013869 — SR IVOCRON
- K021892 — BRIGHT GOLD
- K013802 — FRC POSTEC
- K020253 — 4 ALL (DW286A)
- K020898 — D.SIGN 15 (DW286 B)
- K020183 — PISCES PLUS (DW286 C)
- K014042 — D.SIGN 84
- K013809 — D.SIGN 59
- K013929 — HELIOMOLAR HB TRANSLUCENT SHADES
- K014082 — D.SIGN 53, MODEL NA1012204
- K013584 — EXCITE SELF ETCH
- K013277 — ASTRALIS 7, MODEL 557545
- K013275 — ASTRALIS 10, MODELS # 559588, 561859
Data sourced from openFDA. This site is unofficial and independent of the FDA.