FDA UDI
In Commercial Distribution
🇺🇸 United States
MAARC DENTAL - Sealmax +
DI: 08906110443053
·
Model: 8011/001
·
SHIVA PRODUCTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAARC DENTAL - Sealmax +
- Primary DI
- 08906110443053
- Version / Model
- 8011/001
- Catalog Number
- 8011/001
- 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
- 6ed5c488-ae48-48ba-be43-2fb0f221206e
Device Description
Sealmax+ is a MTA based Bioceramic root canal sealing material supplied in the form of powder and resin. The powder and resin are mixed to produce a root canal sealing material of excellent sealing capacity and tissue compatibility. As a result of its close adaptation to the walls and hydrophobic nature, Sealmax + allows tight sealing of root canal during obturation.
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 |
|---|---|---|---|---|
| 66609 | Dental epoxy resin | A substance intended for professional use as a dental root canal sealant that consists of a chemical-curing epoxy resin material(s); it does not include any additional hardening fillers/components (i.e., not a composite resin). It may be provided as a powder and/or paste intended to be mixed prior to application; dedicated disposable devices associated with application may be included with the resin. 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 | 08906110443053 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240446 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius