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 Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator Orthodontic vibrator
Primary Device ID00852673007240
NIH Device Record Key55e58f0a-661d-40b0-bb42-a9ed1588e847
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcceledent Optima
Version Model NumberASM-20031
Company DUNS117334253
Company NamePROPEL ORTHODONTICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852673007240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYHOrthodontic Vibratory Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-10
Device Publish Date2020-07-31

Devices Manufactured by PROPEL ORTHODONTICS LLC

00852673007240 - Acceledent Optima2020-08-10AcceleDent 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 Optima2020-08-10 AcceleDent Optima is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orth
00852673007103 - VPro2020-03-31 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 - Propel2020-03-18 VPro+
00852673007127 - HyperByte2020-01-23 HyperByte is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth mo
00852673007004 - Propel2020-01-23 Perforation Device, Propel XL
00852673007011 - Propel2020-01-23 C-Shaped Vibration Device
00852673007028 - Propel2020-01-23 Assy. Packaged Perforation Device, Contra-Angle
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