NATURE-CRYL® 349813
GUDID 10386040008020
NATURE-CRYL® SUPER HI IMPACT LIGHT 1:1 PKG (1Ib powder, 8oz liquid)
Gc America Inc.
Dental acrylic resin Dental acrylic resin Dental acrylic resin Dental acrylic resin Dental acrylic resin Dental acrylic resin Dental acrylic resin Dental acrylic resin Dental acrylic resin| Primary Device ID | 10386040008020 |
| NIH Device Record Key | 4bb829ac-5331-40f2-8444-475757b09fff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NATURE-CRYL® |
| Version Model Number | 349813 |
| Catalog Number | 349813 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| 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 | false |
| 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 | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040008020 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051358
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-19 |
| Device Publish Date | 2022-07-11 |
On-Brand Devices [NATURE-CRYL®]
| D6583497031 | NATURE-CRYL ® HI-20ET COE-LOR HEAVY 1Ib POWDER |
| D6583496571 | NATURE-CRYL® MC CLEAR 1Ib POWDER |
| D6583496561 | NATURE-CRYL® MC ORIGINAL 1Ib POWDER |
| D6583496551 | NATURE-CRYL® MC LIGHT REDDISH PINK 1Ib POWDER |
| D6583496541 | NATURE-CRYL® MC LIGHT 1Ib POWDER |
| D6583496531 | NATURE-CRYL® MC COE-LOR HEAVY 1Ib POWDER |
| D6583496521 | NATURE-CRYL® MC COE-LOR MODERATE 1Ib POWDER |
| D6583496511 | NATURE-CRYL® MC COE-LOR MILD 1lb POWDER |
| D6583496501 | NATURE-CRYL® MC LIGHT FIBERED + 1lb POWDER |
| 10386040008280 | NATURE-CRYL® POUR CLEAR 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008273 | NATURE-CRYL® POUR ORIGINAL 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008266 | NATURE-CRYL® POUR LIGHT REDDISH PINK 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008259 | NATURE-CRYL® POUR LIGHT 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008242 | NATURE-CRYL® POUR COE-LOR HEAVY 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008235 | NATURE-CRYL® POUR COE-LOR MODERATE 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008228 | NATURE-CRYL® POUR COE-LOR MILD 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008211 | NATURE-CRYL® POUR COE LIGHT FIBERED + 1:1 PKG (1Ib powder, 300mL liquid) |
| 10386040008204 | NATURE-CRYL® POUR 300mL LIQUID |
| 10386040008198 | NATURE-CRYL® SUPER HI IMPACT HEAVY 25lb POWDER |
| 10386040008181 | NATURE-CRYL® SUPER HI IMPACT MODERATE 25lb POWDER |
| 10386040008174 | NATURE-CRYL® SUPER HI IMPACT MILD 25lb POWDER |
| 10386040008167 | NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 25lb POWDER |
| 10386040008150 | NATURE-CRYL® SUPER HI IMPACT LIGHT 25lb POWDER |
| 10386040008143 | NATURE-CRYL® SUPER HI IMPACT ORIGINAL 25lb POWDER |
| 10386040008136 | NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED+ 25lb POWDER |
| 10386040008129 | NATURE-CRYL® SUPER HI IMPACT 32oz LIQUID |
| 10386040008112 | NATURE-CRYL® SUPER HI IMPACT ORIGINAL 5lb POWDER |
| 10386040008105 | NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 5lb POWDER |
| 10386040008099 | NATURE-CRYL® SUPER HI IMPACT LIGHT 5lb POWDER |
| 10386040008082 | NATURE-CRYL® SUPER HI IMPACT HEAVY 5lb POWDER |
| 10386040008075 | NATURE-CRYL® SUPER HI IMPACT MODERATE 5lb POWDER |
| 10386040008068 | NATURE-CRYL® SUPER HI IMPACT MILD 5lb POWDER |
| 10386040008051 | NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED + 5lb POWDER |
| 10386040008044 | NATURE-CRYL® SUPER HI IMPACT ORIGINAL 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008037 | NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008020 | NATURE-CRYL® SUPER HI IMPACT LIGHT 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008013 | NATURE-CRYL® SUPER HI IMPACT HEAVY 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040008006 | NATURE-CRYL® SUPER HI IMPACT MODERATE 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040007993 | NATURE-CRYL® SUPER HI IMPACT MILD 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040007986 | NATURE-CRYL® SUPER HI IMPACT LIGHT FIBERED + 1:1 PKG (1Ib powder, 8oz liquid) |
| 10386040007979 | NATURE-CRYL® SUPER HI IMPACT 8oz LIQUID |
| 10386040007870 | NATURE-CRYL® POUR LIGHT 25lb POWDER |
| 10386040007863 | NATURE-CRYL® POUR COE-LOR HEAVY 25lb POWDER |
| 10386040007856 | NATURE-CRYL® POUR LIGHT REDDISH PINK 25lb POWDER |
| 10386040007849 | NATURE-CRYL® POUR COE-LOR MODERATE 25lb POWDER |
| 10386040007832 | NATURE-CRYL® POUR COE-LOR MILD 25lb POWDER |
| 10386040007825 | NATURE-CRYL® POUR ORIGINAL 25lb POWDER |
| 10386040007818 | NATURE-CRYL® POUR COE LIGHT FIBERED + 25lb POWDER |
| 10386040007801 | NATURE-CRYL® POUR 32oz LIQUID |
| 10386040007795 | NATURE-CRYL® POUR ORIGINAL 5lb POWDER |
Trademark Results [NATURE-CRYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NATURE-CRYL 78564641 3105228 Live/Registered |
GC America Inc. 2005-02-10 |
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