FDA.report

Resolve Ceramic

Primary DI
D746FRL322R1
Brand
Resolve Ceramic
Company
RAINTREE ESSIX INC.
Model
FRL322R
Catalog number
FRL322R
Device description
Roth Prescription Mandibular Arch Lower Cuspid no Hook .022”
Published
2016-09-24
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

Contact Domains

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D746FRL322R1PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket, ceramicA 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 typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. 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)883-8733sales@essix.com

Regulatory Flags

DUNS number
801157132
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D74627310701VISTADENT® OC27-310-7027-310-702016-09-24
D7462731070U1VISTADENT® OC27-310-70U27-310-70U2016-09-24
D74627310991VISTADENT® OC27-310-9927-310-992016-09-24
D7462731099U1VISTADENT® OC27-310-99U27-310-99U2016-09-24
D7462731170L1VISTADENT® OC27-311-70L27-311-70L2016-09-24
D7462731199L1VISTADENT® OC27-311-99L27-311-99L2016-09-24
D74627313991VISTADENT® OC27-313-9927-313-992016-09-24
D74627314991VISTADENT® OC27-314-9927-314-992016-09-24
D746IEC0011ImprEssix®IEC001IEC0012016-09-24
D746IEC001201ImprEssix®IEC001-20IEC001-202016-09-24
D746825101Thermoplier®82510825102016-09-24
D746825201Thermoplier®82520825202016-09-24
D746825301Thermoplier®82530825302016-09-24
D7468253B1Thermoplier®8253B8253B2016-09-24
D746825401Thermoplier®82540825402016-09-24
D746825501Thermoplier®82550825502016-09-24
D746825601Thermoplier®82560825602016-09-24
D746825701Thermoplier®82570825702016-09-24
D746825901Thermoplier®82590825902016-09-24
D746826041Bonding Buttons82604826042016-09-24

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00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191824Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191831Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191855Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191862Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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