FDA UDI
In Commercial Distribution
🇺🇸 United States
Grandio Seal
DI: E22110601
·
Model: 1060
·
VOCO GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Grandio Seal
- Primary DI
- E22110601
- Version / Model
- 1060
- Catalog Number
- 1060
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-06-05
- Public Version
- 1
- Public Version Date
- 2019-06-13
- Public Version Status
- New
- Public Device Record Key
- e6b24c94-586b-4031-9946-91a5fade0478
Device Description
Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant with outstanding mechanical properties.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | 872.3765 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34771 | Dental unfilled resin sealant/coating | A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E22110601 | HIBCC | ||||
| Unit of Use | E2211060 | HIBCC |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062344 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 23 Degrees Celsius