FDA UDI
In Commercial Distribution
🇺🇸 United States
MAARC DENTAL-Calahyd-RC
DI: 08906110440014
·
Model: 9103/15x2
·
SHIVA PRODUCTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAARC DENTAL-Calahyd-RC
- Primary DI
- 08906110440014
- Version / Model
- 9103/15x2
- Catalog Number
- 9103/15x2
- 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
- 2
- Public Version Date
- 2025-03-18
- Public Version Status
- Update
- Public Device Record Key
- ab21e272-852b-48b9-8d6f-723c2d738772
Device Description
Calahyd – RC is a silicon oil based yellowish paste consisting of premixed Calcium Hydroxide and Iodoform. Supplied in a multi dose syringe with disposable pre-bent cannulas for dispensing. Used to prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition.
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 |
|---|---|---|---|---|
| 60275 | Endodontic temporary cement | A viscous material intended for the temporary obturation of a prepared root canal, to maintain relative sterility between procedures and facilitate healing. Commonly referred to as temporary filling or sealer, it is typically a zinc or calcium cement-based paste that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a prefilled tube or syringe; some types require the use of a separate sealer. 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 | 08906110440014 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240446 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius