FDA UDI
In Commercial Distribution
🇺🇸 United States
MAARC DENTAL -Rootfyx
DI: 08906110443039
·
Model: 9107/0.5x4
·
SHIVA PRODUCTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAARC DENTAL -Rootfyx
- Primary DI
- 08906110443039
- Version / Model
- 9107/0.5x4
- Catalog Number
- 9107/0.5x4
- Company Name
- SHIVA PRODUCTS
- Labeler DUNS
- 737988276
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-02
- Public Version
- 1
- Public Version Date
- 2024-10-10
- Public Version Status
- New
- Public Device Record Key
- 276dc6ac-a8f1-4e15-801d-025b9d833e5c
Device Description
Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately inserted into the root canal using a disposable tip. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60510 | Hygroscopic dental cement | A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08906110443039 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240446 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius