FDA.report

Therma-Ti

Primary DI
00190746054792
Brand
Therma-Ti
Company
AMERICAN ORTHODONTICS CORPORATION
Model
858-550IDSP
Catalog number
858-550IDSP
Device description
WIRE THERMA-TI LOWER 016 X 016 FORM III W/DIMPLE 10/PKG
Published
2017-10-20
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

Related Records

Product Codes

CodeName
DZCWIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190746054792PrimaryGS10

GMDN Terms

TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags

DUNS number
044668515
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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00190746191657Empower Bracket475-410VSCC475-410VSCC2026-03-23
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00190746191671Empower Bracket585-140BVSCC585-140BVSCC2026-03-23
00190746191688Empower Bracket585-140VSCC585-140VSCC2026-03-23
00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
00190746191701Empower Bracket585-240BVSCC585-240BVSCC2026-03-23
00190746191718Empower Bracket585-240VSCC585-240VSCC2026-03-23
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Other Devices Sharing Product Codes

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00840479203621RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
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00840479203263RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
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00840479203300RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
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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
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00840479203171RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
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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
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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