FDA UDI
In Commercial Distribution
🇺🇸 United States
Atlas Dual Cure Cement
DI: D83610051
·
Model: 1005
·
DENT ZAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Atlas Dual Cure Cement
- Primary DI
- D83610051
- Version / Model
- 1005
- Catalog Number
- 1005
- Company Name
- DENT ZAR, INC.
- Labeler DUNS
- 789664455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9961c7d2-e3d0-4e11-9af1-8adfe6dafda4
Device Description
Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL •Excellent handling characteristics •Dual-Cured •Fluoride release •X-ray opacity •Low irritation potential •Negligible solubility •Low film thickness •Excellent resistance to oral environment and mechanical strength assure good long-term performance •Long shelf life
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | 872.3750 | 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 | D83610051 | HIBCC | ||||
| Unit of Use | D83610050 | HIBCC |