FDA.reportPublic FDA data

Elastomeric Band

Primary DI
00840273922018
Brand
Elastomeric Band
Company
World Class Technology Corporation
Model
60.63.865.00045
Catalog number
60.63.865.00045
Device description
"LE 5/16"" 8mm 4.5 Heavy (50 PK)"
Published
2023-10-27
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
ECIBand, Elastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840273922018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273922018008402739220188402739220180840273922018

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic inter-arch elastic bandA non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

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
Expiration 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205020JMUJMU DENTAL, INCECI2026-06-22
00840456205037JMUJMU DENTAL, INCECI2026-06-22
00840456205044JMUJMU DENTAL, INCECI2026-06-22
00840456205051JMUJMU DENTAL, INCECI2026-06-22
00840456205068JMUJMU DENTAL, INCECI2026-06-22
00840456205075JMUJMU DENTAL, INCECI2026-06-22
00840456205082JMUJMU DENTAL, INCECI2026-06-22
00840456205099JMUJMU DENTAL, INCECI2026-06-22
00840456205105JMUJMU DENTAL, INCECI2026-06-22
00840456205112JMUJMU DENTAL, INCECI2026-06-22
00840456205129JMUJMU DENTAL, INCECI2026-06-22
00840456205136JMUJMU DENTAL, INCECI2026-06-22
00840456205143JMUJMU DENTAL, INCECI2026-06-22
00840456205150JMUJMU DENTAL, INCECI2026-06-22
00840456205167JMUJMU DENTAL, INCECI2026-06-22
00840456205174JMUJMU DENTAL, INCECI2026-06-22
00840456205181JMUJMU DENTAL, INCECI2026-06-22
00840456205198JMUJMU DENTAL, INCECI2026-06-22
00840456205204JMUJMU DENTAL, INCECI2026-06-22
00840456205211JMUJMU DENTAL, INCECI2026-06-22
00840456205228JMUJMU DENTAL, INCECI2026-06-22
00840456205235JMUJMU DENTAL, INCECI2026-06-22
00840456205242JMUJMU DENTAL, INCECI2026-06-22
00840456205259JMUJMU DENTAL, INCECI2026-06-22
00840456205426JMUJMU DENTAL, INCECI2026-06-22
00840456205433JMUJMU DENTAL, INCECI2026-06-22
00840456205440JMUJMU DENTAL, INCECI2026-06-22
00840456205457JMUJMU DENTAL, INCECI2026-06-22
00840456205464JMUJMU DENTAL, INCECI2026-06-22
00840456205471JMUJMU DENTAL, INCECI2026-06-22