FDA.reportPublic FDA data

Bands & Attachments

Primary DI
00840273919094
Brand
Bands & Attachments
Company
World Class Technology Corporation
Model
34.30.120.00335
Catalog number
34.30.120.00335
Device description
FMB RU 33.5
Published
2024-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYOBand, Material, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYOBand, Material, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840273919094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273919094008402739190948402739190940840273919094

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
866-752-0065info@oc-orthodontics.com

Regulatory Flags#

DUNS number
961810017
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840273922575APII960.00052026-02-25
00840273922582APII960.00012026-02-25
00840273922629Crimpable Attachments906.0007-20906.0007-202026-02-25
00840273922636Crimpable Attachments906.0008-202026-02-25
00840273919063Bands & Attachments34.30.120.0030534.30.120.003052024-03-14
00840273919070Bands & Attachments34.30.120.0031534.30.120.003152024-03-14
00840273919087Bands & Attachments34.30.120.0032534.30.120.003252024-03-14
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
00840273918714Bands & Attachments33.30.210.0001933.30.210.000192024-02-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974720061198Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061204Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061211Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061228Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061235Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
06974720061242Dental SheetSichuan Yaqi Medical Technology Co., Ltd.DYO2026-05-21
006522210247323M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-05-07
006522213044453M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213044523M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-28
006522213029843M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213029913M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
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006522213031033M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031343M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031413M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031583M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031723M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213031963M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032023M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032193M™ Unitek™ Lingual Sheaths3M UNITEK CORPORATIONDYO2026-04-25
006522213032263M™ Unitek™3M UNITEK CORPORATIONDYO2026-04-25