Bioliner Plus

GUDID D82851001560

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic retainer
Primary Device IDD82851001560
NIH Device Record Keyf2dbf280-20bf-4df4-87e6-cecefbab5eac
Commercial Distribution Discontinuation2023-02-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBioliner Plus
Version Model Number5100156
Company DUNS113352686
Company NameFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
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
HIBCCD82851001560 [Primary]

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-10

Devices Manufactured by FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

D82850001900 - Twin Block2024-10-21
D82853004020 - Rickonator2024-10-21
D82851001560 - Bioliner Plus2023-02-20
D82851001560 - Bioliner Plus2023-02-20
D82852000920 - Vivos mmRNA2021-11-29
D8281330003 - FUJI SC BAND PASTE PAK2018-07-06
D8281330121 - FUJI LC BAND AUTOMIX2018-07-06
D8281330171 - ULTRA BAND LOK CLEAR2018-07-06
D8281330205 - LIGHT BOND PASTE TIPS2018-07-06

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