Acceledent Optima

GUDID 00852673007240

AcceleDent Optima is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and aligners to help facilitate minor anterior tooth movement.

PROPEL ORTHODONTICS LLC

Orthodontic vibrator

• Primary Device ID: 00852673007240
• NIH Device Record Key: 55e58f0a-661d-40b0-bb42-a9ed1588e847
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acceledent Optima
• Version Model Number: ASM-20031
• Company DUNS: 117334253
• Company Name: PROPEL ORTHODONTICS LLC
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852673007240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170093

FDA Product Code

• OYH: Orthodontic Vibratory Accessory

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: 2020-08-10
• Device Publish Date: 2020-07-31

Devices Manufactured by PROPEL ORTHODONTICS LLC

• 00852673007240 - Acceledent Optima: 2020-08-10AcceleDent Optima is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and aligners to help facilitate minor anterior tooth movement.
• 00852673007240 - Acceledent Optima: 2020-08-10 AcceleDent Optima is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orth
• 00852673007103 - VPro: 2020-03-31 VPro is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth movemen
• 00852673007189 - VPro+: 2020-03-25 VPro+ is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth moveme
• 00852673007097 - Propel: 2020-03-18 VPro+
• 00852673007127 - HyperByte: 2020-01-23 HyperByte is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth mo
• 00852673007004 - Propel: 2020-01-23 Perforation Device, Propel XL
• 00852673007011 - Propel: 2020-01-23 C-Shaped Vibration Device
• 00852673007028 - Propel: 2020-01-23 Assy. Packaged Perforation Device, Contra-Angle