FDA.report

2nd Molar Pre-Fit Band

Primary DI
00192029049068
Brand
2nd Molar Pre-Fit Band
Company
TP ORTHODONTICS INC
Model
946-725
Device description
BAND ORDER
Published
2021-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192029049068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029049068001920290490681920290490680192029049068

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

Regulatory Flags

DUNS number
005432299
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
false
Sterilization required before use
false

Other Devices From This Company

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00192029050538Tip-Edge PLUS Stainless Steel Brackets296-61122025-02-04
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00192029050552Tip-Edge PLUS Stainless Steel Brackets296-61322025-02-04
00192029050569Tip-Edge PLUS Stainless Steel Brackets296-61422025-02-04
00192029050576Tip-Edge PLUS Stainless Steel Brackets296-61522025-02-04
00192029050583Tip-Edge PLUS Stainless Steel Brackets296-61622025-02-04
00192029050590Tip-Edge PLUS Stainless Steel Brackets296-61722025-02-04
00192029050606Tip-Edge PLUS Stainless Steel Brackets296-61822025-02-04
00192029050613Tip-Edge PLUS Stainless Steel Brackets296-61922025-02-04
00192029050620Tip-Edge PLUS Stainless Steel Brackets296-62022025-02-04
00192029050637Tip-Edge PLUS Stainless Steel Brackets296-62322025-02-04
00192029050644Tip-Edge PLUS Stainless Steel Brackets296-62422025-02-04
00192029050651Tip-Edge PLUS Stainless Steel Brackets296-62522025-02-04
00192029050668Tip-Edge PLUS Stainless Steel Brackets296-62622025-02-04
00192029050675Tip-Edge PLUS Stainless Steel Brackets296-62922025-02-04
00192029050682Tip-Edge PLUS Stainless Steel Brackets296-63022025-02-04
00192029050699Tip-Edge PLUS Stainless Steel Brackets296-63122025-02-04
00192029050705Tip-Edge PLUS Stainless Steel Brackets296-63222025-02-04
00192029050712Tip-Edge PLUS Stainless Steel Brackets296-63322025-02-04
00192029050729Tip-Edge PLUS Stainless Steel Brackets296-63422025-02-04

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