Nacera 4000LQ7063
GUDID EDMC4000LQ70630
Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium oxide, especially for Nacera® Pearl 1. 16 + 2 shades, 4 effect liquids, balancer, diluting.
DOCERAM medical ceramics GmbH
Dental appliance fabrication material, ceramic| Primary Device ID | EDMC4000LQ70630 |
| NIH Device Record Key | dc5f3135-9d52-4d96-b117-a12c6a41014f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nacera |
| Version Model Number | Classic Liquid Body D2 |
| Catalog Number | 4000LQ7063 |
| Company DUNS | 537713567 |
| Company Name | DOCERAM medical ceramics GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us | |
| Phone | +49231925025952 |
| RA@nacera.us |
Device Dimensions
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
| Total Volume | 50 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMC4000LQ70630 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092020
FDA Product Code
| EIH | Powder, Porcelain |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 8 |
| Public Version Date | 2020-02-10 |
| Device Publish Date | 2016-12-19 |
On-Brand Devices [Nacera]
| EDMC4000LQ80300 | Translucent liquid. Increases translucency in the incisal area where applied. Only allowed to be |
| EDMC34923000470 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34923000460 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34923000450 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34923000440 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34913000630 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34913000620 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34913000610 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34913000600 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34903000620 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34903000610 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34903000600 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC34903000590 | 6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded |
| EDMC3293WN30990 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3293WN30950 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3293WN30940 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3292WN30990 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3292WN30950 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3292WN30940 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3291WN30990 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3291WN30950 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC3291WN30940 | 3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded, mult |
| EDMC45033000020 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45033000010 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45033000000 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45023000030 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45023000020 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45023000010 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45023000000 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45013000040 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45013000030 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45013000020 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC45013000010 | Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades |
| EDMC4000LQ80370 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ80360 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ80330 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ80310 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ80270 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ80210 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ80200 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71160 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71150 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71140 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71130 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71120 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71110 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71100 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71090 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71080 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
| EDMC4000LQ71070 | Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium ox |
Trademark Results [Nacera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NACERA 79130366 4531312 Live/Registered |
DOCERAM GmbH 2013-02-28 |
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