FDA.report

IN-OVATION® C

Primary DI
D807100332001
Brand
IN-OVATION® C
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
100-332-00
Catalog number
100-332-00
Device description
IN-OVATION® C Base Rx 022/LR3 -11T 7A 2M
Published
2017-06-26
Public version status
Update
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
NJMBracket, ceramic, orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D807100332001PrimaryHIBCC0
D807100332000Unit of UseHIBCC0

GMDN Terms

TermDefinition
Self-ligating orthodontic bracketA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. 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(631)357-8600CustomerService_GAC@dentsplysirona.com

Regulatory Flags

DUNS number
116903307
Device count
5
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

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00190746198595Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
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