FDA.report

Andrews2™

Primary DI
00190707102579
Brand
Andrews2™
Company
ORTHO ORGANIZERS, INC.
Model
112-173
Device description
.018 x .025 LO Andrews²™ Ortholoy-Blue .46 x .64mm Archwire (10)
Published
2022-10-17
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

Product Codes

CodeName
DZCWIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707102579PrimaryGS10

GMDN Terms

TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
1
DM exempt
true
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

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00190707096793Reveal® Aligners139-61092022-01-06
00190707096809Reveal® Aligners139-61082022-01-06
00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840479203621RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203256RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203263RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203294RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203300RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203461ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203133RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203140RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203157RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203164RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203171RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203188RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203195RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203201RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203218RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479202198ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202204ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202235ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202242ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479201146DISPOSABLE C&C OVAL APPLICATOR WITHOUT CHAIN (1)RELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-04
00840479201153DISPOSABLE C&C PAD ATTACHMENT WITH CHAIN (1)RELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-04
00840479200828BOND A BRAID 6 INCH LINGUAL RETAINER WIRESRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-23
00840479200415RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200422RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200439RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200446RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200453RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200460RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20