AH Plus Bioceramic Sealer

GUDID D075BKTAHBS0000001

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. 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.

MARUCHI

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• Primary Device ID: D075BKTAHBS0000001
• NIH Device Record Key: e8d7c96c-f4d1-4043-bb36-3930c939f13d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AH Plus Bioceramic Sealer
• Version Model Number: Starter Kit
• Company DUNS: 557821685
• Company Name: MARUCHI
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D075BKTAHBS0000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212229

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [AH Plus Bioceramic Sealer]

• D075BKTAHBS0000001: 1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pr
• D075B00AHBS10003G2: 1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pr