FDA.report

BioMIM Mini Twin Brackets

Primary DI
00840273901464
Brand
BioMIM Mini Twin Brackets
Company
World Class Technology Corporation
Model
901.1009-100
Catalog number
901.1009-100
Device description
MB UL/UR4,5 18/-7/0/0 100PK
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840273901464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273901464008402739014648402739014640840273901464

GMDN Terms

TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
866-752-0065info@oc-orthodontics.com

Regulatory Flags

DUNS number
961810017
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840273922575APII960.00052026-02-25
00840273922582APII960.00012026-02-25
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00840273922636Crimpable Attachments906.0008-202026-02-25
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00840273919070Bands & Attachments34.30.120.0031534.30.120.003152024-03-14
00840273919087Bands & Attachments34.30.120.0032534.30.120.003252024-03-14
00840273919094Bands & Attachments34.30.120.0033534.30.120.003352024-03-14
00840273919100Bands & Attachments34.30.120.0034534.30.120.003452024-03-14
00840273919117Bands & Attachments34.30.120.0035534.30.120.003552024-03-14
00840273919124Bands & Attachments34.30.120.0036534.30.120.003652024-03-14
00840273919131Bands & Attachments34.30.120.0037534.30.120.003752024-03-14
00840273919155Bands & Attachments34.30.120.0039534.30.120.003952024-03-14
00840273919162Bands & Attachments34.30.120.0040534.30.120.004052024-03-14
00840273918653Bands & Attachments33.30.210.0001333.30.210.000132024-02-29
00840273918660Bands & Attachments33.30.210.0001433.30.210.000142024-02-29
00840273918677Bands & Attachments33.30.210.0001533.30.210.000152024-02-29
00840273918684Bands & Attachments33.30.210.0001633.30.210.000162024-02-29
00840273918691Bands & Attachments33.30.210.0001733.30.210.000172024-02-29
00840273918707Bands & Attachments33.30.210.0001833.30.210.000182024-02-29

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