FDA.report

Mini Skirt Crowns

Primary DI
00190746039744
Brand
Mini Skirt Crowns
Company
AMERICAN ORTHODONTICS CORPORATION
Model
173302-0R-0500
Catalog number
173302-0R-0500
Device description
CROWN MINI SKIRT LR 1ST MOLAR SZ 5 W/20.5MM CANTILEVER BAR
Published
2020-01-22
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

Contact Domains

Product Codes

CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190746039744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746039744001907460397441907460397440190746039744

GMDN Terms

TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be 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
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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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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