Product code EIH— Dental
Dental Zirconia Ceramic
- Classification name
- Powder, Porcelain
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Total cleared
- 487
- First cleared
- Most recent
Market context for product code EIH
FDA has cleared devices under product code EIH between 1977 and 2026, filed by 225 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code EIH
Recent clearances under product code EIH
1–100 of 487- K262074 — Any-Zircos
- K262239 — Obsidian® Press Over Zirconia
- K261046 — Dental Zirconia Blank & Coloring Liquid
- K262195 — Dandy Ceramic Stain and Glaze
- K260918 — Zolid Lunaris
- K260859 — Rosetta SM, Rosetta SP
- K253191 — DCMhotbond zircon
- K260067 — Eternal Art Porcelain Powders
- K260370 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K253953 — IPS e.max Zirconia
- K254283 — BruxZir® Shaded 16 PLUS
- K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
- K252789 — Glass Ceramic
- K252446 — BruxZir® NOW
- K251593 — DenMat Multilayered Zirconia Disc
- K250063 — ARENA Star, Galaxy Star
- K250826 — Multi M Series
- K251084 — zirkon; structure; LFU shades, stains and glazes
- K250673 — CERABIEN MiLai
- K250534 — Biomic Color Opaque
- K250393 — ZircaGlow & ZircaGlow HT Zirconia
- K250811 — Dental Zirconia Ceramic
- K250025 — Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
- K250223 — BruxZir® Esthetic NOW
- K243940 — VITA YZ Multi Translucent
- K242740 — Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
- K242521 — Estar-ZE
- K242407 — Dental Glass Ceramics Blocks (HT, LT, MT)
- K242458 — ArgenZ MTZ
- K242462 — CEREC Cercon 4D CAD/CAM Blocks
- K242400 — Dental porcelain powder
- K241151 — LUXEN 5G
- K233064 — Copra Supreme
- K241579 — DD Hybridlayer (multicolored zirconia)
- K241602 — Kingcera Dental Zirconia Blank
- K241557 — Cercon® yo ML
- K241715 — Dental Glass Ceramics Blocks (HT,LT,ST)
- K241316 — Zirconia Block
- K232952 — Copran Zri
- K233885 — rainbow Paste Stain SE
- K233158 — Copra Smile, Copra Supreme Hyperion
- K240672 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
- K240912 — Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
- K240772 — Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
- K240882 — BruxZir® Esthetic
- K240419 — UltraThineer Zirconia Slurry (5Y-B)
- K240574 — BruxZir® Radiant
- K232682 — Pre-Sintered Zirconia Coloring Liquid
- K234014 — Obsidian® NOW
- K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
- K232673 — Dental Glass Ceramics
- K232676 — Dental Porcelain Powder
- K233125 — Zirconia Block
- K233016 — Dental Glass Ceramics
- K232438 — Dental Glass Ceramics Blocks
- K231687 — Gradual Dental Zirconia Blank
- K230487 — Dental Lithium Disilicate Glass-Ceramic
- K231264 — Easy On Universal Glaze & Stain
- K223029 — Perfit CL
- K231347 — BruxZir TintEFX Coloring Liquid
- K222961 — Harvest Conceal ZR Block Out
- K230259 — Soreal Press, Soreal CAD
- K230262 — BruxZir Incisal Coloring Liquid
- K230003 — Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K223192 — XT Stain/Glaze
- K223253 — Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
- K222513 — Glass Ceramics
- K223194 — Glass Ceramic
- K213722 — ICE Ceramics, ICE Stains, Fresco
- K222626 — Dental Zirconia Ceramic
- K222520 — Zirconia Block
- K222686 — Perfit FS Dental Zirconia Fully Sintered Block
- K220369 — Esthetic Colorant
- K220816 — BruxZir NOW
- K221242 — Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K221429 — KDF Zirconia Disc
- K221051 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K220017 — Coloring Liquid
- K220960 — BruxZir Opaque Coloring Liquid
- K213147 — CERABIEN MiLai
- K212939 — Vintage Prime Press
- K214003 — Dental Zirconia Pre-shaded Block
- K214005 — Zirconia Dental Ceramics
- K213570 — Dental Zirconia Ceramic
- K212548 — LUXEN CL Dental Liquid
- K213425 — BruxZir Esthetic
- K212765 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K212259 — Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K211308 — INNI-CERA
- K202952 — Amber Mill Q Series & Amber Mill Direct Series
- K211916 — IPS e.max One
- K210884 — 1Derful HS, 1Derful HT
- K210097 — Estar-Z
- K203672 — MAZIC Claro CAD and MAZIC Claro Press
- K203590 — Perfit FS Dental Zirconia Fully Sintered Block
- K203499 — Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
- K201492 — Non-Sterile Zirconia Block
- K203351 — Perfit ZR HT Dental Zirconia blank
- K201915 — GenesisZr 4Y+ (ST1100) Zirconia
- K201608 — GenesisZr UHT700 Zirconia
Data sourced from openFDA. This site is unofficial and independent of the FDA.