FDA UDI
In Commercial Distribution
🇺🇸 United States
SCOTT'S SELECT TEMP AUTOMIX NE 11gm
DI: D77819910451
·
Model: 199-1045
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SCOTT'S SELECT TEMP AUTOMIX NE 11gm
- Primary DI
- D77819910451
- Version / Model
- 199-1045
- Catalog Number
- 199-1045
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-02
- Public Version
- 6
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- ad9a552f-db4f-4a33-afe9-d4ef3b0ade8d
Device Description
Non-eugenol temporary cement
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
- Yes
- 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 |
|---|---|---|---|---|
| EMA | Cement, Dental | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62200 | Zinc oxide eugenol dental cement | A non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components (e.g., rosin/colophony). 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 | D77819910451 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 11 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 25 Degrees Celsius