AH Plus Bioceramic Sealer
Basic Information
- Brand Name
- AH Plus Bioceramic Sealer
- Primary DI
- D075B00AHBS10003G2
- Version / Model
- Syringe Refill
- Catalog Number
- 00093
- Company Name
- MARUCHI
- Labeler DUNS
- 557821685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-23
- Public Version
- 1
- Public Version Date
- 2023-07-03
- Public Version Status
- New
- Public Device Record Key
- 7799c3b7-4ee6-4c76-87db-7e518b74548e
Device Description
1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones. 2. Principle of operation: AH Plus Bioceramic Sealer is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. AH Plus Bioceramic Sealer between the root canal and the root canal filling materials(ex. Gutta percha) by using sealing properties. 3. Storage conditions: 1) The product must be stored at room temperature (15 - 25°C) avoiding high temperature and humidity. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture.
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
- 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 |
|---|---|---|---|---|
| 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 | D075B00AHBS10003G2 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212229 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius