Nacera 4501300004
GUDID EDMC45013000040
Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades. Flexural strength: 175 MPa (typical value). Modulus of elasticity: 9900 MPa (typical value).
DOCERAM medical ceramics GmbH
Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic| Primary Device ID | EDMC45013000040 |
| NIH Device Record Key | f79f9e43-ba5d-4976-844e-bbe48e059e46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nacera |
| Version Model Number | Hybrid A1 Block M |
| Catalog Number | 4501300004 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDMC45013000040 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130654
FDA Product Code
| EBF | Material, Tooth Shade, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2019-04-02 |
| Device Publish Date | 2017-11-17 |
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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