FDA.reportPublic FDA data

Separators

Primary DI
00190746170829
Brand
Separators
Company
AMERICAN ORTHODONTICS CORPORATION
Model
854-034080
Catalog number
854-034080
Device description
ELASTOMERIC SEPARATORS RADIO OPAQUE SMALL BLUE .040 THICK 1/8 OD
Published
2021-06-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00190746170829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746170829001907461708291907461708290190746170829

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic separatorA non-surgical orthodontic device typically in the form of a loop or ring intended to be placed between adjacent teeth to slowly move them apart to help achieve improved positioning and/or appearance of the teeth; it is not intended for separation of tooth roots. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light, Keep Dry
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190746189258Buccal Tubes851-110851-1102022-03-24
00190746189272Buccal Tubes851-121851-1212022-03-24
00190746189432Buccal Tubes851-182851-1822022-03-24
00190746141249Stainless Steel Brackets002-0070HMURWF002-0070HMURWF2021-09-03
00190746141263Stainless Steel Brackets002-0071HMULWF002-0071HMULWF2021-09-03
00190746141454Stainless Steel Brackets002-477HDLLWF002-477HDLLWF2021-09-03
00190746141461Stainless Steel Brackets002-477HDLRWF002-477HDLRWF2021-09-03
00190746141515Stainless Steel Brackets002-494HDLLWF002-494HDLLWF2021-09-03
00190746141522Stainless Steel Brackets002-494HDLRWF002-494HDLRWF2021-09-03
00190746175442Stainless Steel Brackets092-208BUL092-208BUL2021-09-03
00190746175459Stainless Steel Brackets092-208BUR092-208BUR2021-09-03
00190746176296Stainless Steel Brackets097-211UL097-211UL2021-09-03
00190746176302Stainless Steel Brackets097-211UR097-211UR2021-09-03
00190746177996Stainless Steel Brackets593-004593-0042021-09-03
00190746161575Stainless Steel Brackets091-142BUL091-142BUL2021-08-26
00190746174957Stainless Steel Brackets091-142BUR091-142BUR2021-08-26
00190746175268Stainless Steel Brackets092-006BUL092-006BUL2021-08-26
00190746175275Stainless Steel Brackets092-006BUR092-006BUR2021-08-26
00190746175503Stainless Steel Brackets092-444HDLR092-444HDLR2021-08-26
00190746175510Stainless Steel Brackets092-445HDLL092-445HDLL2021-08-26

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