Monolith Prophy Paste Xtra COARSE "Spearmint" Tube

GUDID 04064896000106

PRISMAN INC.

Dental abrasive powder

• Primary Device ID: 04064896000106
• NIH Device Record Key: 66cd4cd4-340d-4034-b68f-919a90782e3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monolith Prophy Paste Xtra COARSE "Spearmint" Tube
• Version Model Number: M505
• Company DUNS: 117569946
• Company Name: PRISMAN INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04064896000106 [Primary]

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral Cavity

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: 2021-10-18
• Device Publish Date: 2021-10-10

Devices Manufactured by PRISMAN INC.

• 04064896000564 - PWR Classic Powder Mint: 2024-11-01 Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel.
• 04064896000571 - PWR Classic Powder Neutral: 2024-11-01 Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel.
• 04064896000601 - PWR Perio Powder Mint: 2024-11-01 Prophylaxis powder based on non-cariogenic glycine (approx. 25µ). For the gentle, abrasive removal of supra- and subgingival pl
• 04064896000625 - PWR Perio Powder Neutral: 2024-11-01 Prophylaxis powder based on non-cariogenic glycine (approx. 25µ). For the gentle, abrasive removal of supra- and subgingival pl
• 04064896000014 - Air Supra: 2024-08-05 Prophylaxis powder based on non-cariogenic spherical calciumcarbonate (45µ). For the effective removal of supragingivial plaque
• 04064896000038 - Air Supreme: 2024-08-05 Prophylaxis powder based on non-cariogenic tagatose (15µ). For the gentle abrasive removal of supra- and subgingival plaque and
• 04064896000267 - Monolith InstruZyme conc.: 2022-01-17
• 04064896000427 - Monolith InstruZyme Powder conc.: 2022-01-17