Ormco™ EtchFree Bonding
GUDID 10889989088912
ORMCO ETCHFREE BONDING PRIMER, REPOSITION VIALS REFILL
ORMCO CORPORATION
Dental etching solution| Primary Device ID | 10889989088912 |
| NIH Device Record Key | 6c09d448-a1bc-4c3c-96a1-313f4b18ebe9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ormco™ EtchFree Bonding |
| Version Model Number | 740-0525 |
| Company DUNS | 154614119 |
| Company Name | ORMCO CORPORATION |
| Device Count | 25 |
| 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 | true |
| 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 | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com | |
| Phone | +18008541741 |
| ormcocustcare@ormco.com |
Device Dimensions
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
| Total Volume | 0.15 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889989088915 [Primary] |
| GS1 | 10889989088912 [Unit of Use] |
FDA Product Code
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
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 | 2025-05-19 |
| Device Publish Date | 2025-05-09 |
On-Brand Devices [Ormco™ EtchFree Bonding]
| 10889989088912 | ORMCO ETCHFREE BONDING PRIMER, REPOSITION VIALS REFILL |
| 00889989088908 | ORMCO ETCHFREE BONDING STARTER KIT |
| 00889989088892 | ORMCO ETCHFREE ADHESIVE, SYRINGE REFILL |
| 10889989088882 | ORMCO ETCHFREE BONDING PRIMER, SINGLE PATIENT VIALS REFILL |
Trademark Results [Ormco]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORMCO 72197753 0805280 Live/Registered |
ORMCO CORPORATION 1964-07-13 |
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