FDA.report

TNT

Primary DI
D798OSSL16251
Brand
TNT
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
OSSL1625
Catalog number
OSSL1625
Device description
Tried and True (TNT) Ovoid Stainless Steel Lower Archwires Size 0.025 x 0.025 mm
Published
2018-06-08
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
D798OSSL16251PrimaryHIBCC0
D798OSSL16250Unit of UseHIBCC0

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
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
25
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
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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00840479203621RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
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00840479203201RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
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