Harvard PremiumFlow Incisal
- Primary DI
- EHAR70822171
- Brand
- Harvard PremiumFlow Incisal
- Company
- Harvard Dental International GmbH
- Model
- 7082217
- Device description
- Flowable light cure nano-hybrid composite for restorations
- Published
- 2016-10-21
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EHAR70822171 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 4 Degrees Celsius | 25 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +493099289780 | info@harvard-dental-international.de |
Regulatory Flags
- DUNS number
- 341553293
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| EHAR70837011 | Harvard PremiumSil Light | 7083701 | | 2016-09-15 |
| EHAR70837021 | Harvard PremiumSil Light Fast | 7083702 | | 2016-09-15 |
| EHAR70837111 | Harvard PremiumSil Medium | 7083711 | | 2016-09-15 |
| EHAR70837121 | Harvard PremiumSil Medium Fast | 7083712 | | 2016-09-15 |
| EHAR70837211 | Harvard PremiumSil Mono | 7083721 | | 2016-09-15 |
| EHAR70837221 | Harvard PremiumSil Mono Fast | 7083722 | | 2016-09-15 |
| EHAR70837311 | Harvard PremiumSil Heavy | 7083731 | | 2016-09-15 |
| EHAR70837321 | Harvard PremiumSil Heavy Fast | 7083732 | | 2016-09-15 |
| EHAR70837331 | Harvard PremiumSil Heavy MaxiMix | 7083733 | | 2016-09-15 |
| EHAR70837401 | Harvard PremiumSil Putty Soft MaxiMix | 7083740 | | 2016-09-15 |
| EHAR70837411 | Harvard PremiumSil Putty Soft | 7083741 | | 2016-09-15 |
| EHAR70837421 | Harvard PremiumSil Putty Soft Fast | 7083742 | | 2016-09-15 |
| EHAR70837511 | Harvard PremiumSil Putty | 7083751 | | 2016-09-15 |
| EHAR70837521 | Harvard PremiumSil Putty Fast | 7083752 | | 2016-09-15 |
| EHAR177081 | Harvard Temp Cem | 17708 | | 2016-09-15 |
| EHAR177201 | Harvard Implant Semi-permanent | 17720 | | 2016-09-15 |
| EHAR177221 | Harvard Temp C&B A2 | 17722 | | 2016-09-15 |
| EHAR177241 | Harvard ZirconCore A3 | 17724 | | 2016-09-15 |
| EHAR177271 | Harvard Ionoresin Fill OptiCaps A2 | 17727 | | 2016-09-18 |
| EHAR177291 | Harvard Ionoglas Fill Extra OptiCaps A2 | 17729 | | 2016-09-18 |
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