FDA UDI
In Commercial Distribution
🇺🇸 United States
SCOTT'S SELECT MICROHYBRID COMPULES 15-.3 Gm (A3.5)
DI: D77819923331
·
Model: 199-2333
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
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Basic Information
- Brand Name
- SCOTT'S SELECT MICROHYBRID COMPULES 15-.3 Gm (A3.5)
- Primary DI
- D77819923331
- Version / Model
- 199-2333
- Catalog Number
- 199-2333
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2017-05-04
- Public Version
- 5
- Public Version Date
- 2020-08-26
- Public Version Status
- Update
- Public Device Record Key
- c12cc328-6d78-4759-be43-756e2856cfdf
Device Description
Microhybrid composite restorative material. Light-Cure Dental Composite for the aesthetic restoration of anterior and posterior teeth. Radiopaque resin based dental restorative material. Shade/color: A3.5. SDS and Instructions for use available at: https://www.scottsdental.com/catalog/product/view/id/23294/s/microhybrid-composite-compules-scott-s- select/
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D77819923331 | HIBCC | ||||
| Unit of Use | D77819923330 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | .3 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius