Emdogain 075.113
GUDID 07630031700087
Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml and 6 blunt needles
Institut Straumann AG
Periodontal root surface regeneration material| Primary Device ID | 07630031700087 |
| NIH Device Record Key | 3f69de60-ec62-4cef-b3b6-fd5606be2dc5 |
| Commercial Distribution Discontinuation | 2019-02-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Emdogain |
| Version Model Number | 1 |
| Catalog Number | 075.113 |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| 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 | 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 | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com | |
| Phone | 800 448 8168 |
| info.usa@straumann.com |
Device Dimensions
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
| Total Volume | 0.3 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Sunnlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031700087 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P930021
FDA Product Code
| NQA | Biologic Material, Dental |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [Emdogain]
| 07630031700100 | Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann® |
| 07630031700087 | Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml an |
| 07630031700025 | Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann® |
Trademark Results [Emdogain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMDOGAIN 86691528 4901495 Live/Registered |
Straumann Holding AG 2015-07-13 |
 EMDOGAIN 74655961 1990962 Live/Registered |
BIOVENTURES BV 1995-04-04 |
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