FDA.reportPublic FDA data

Resolve Ceramic

Primary DI
D746FRL4181
Brand
Resolve Ceramic
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
FRL418
Catalog number
FRL418
Device description
Roth Prescription Mandibular Arch Lower 1st Bicuspid no Hook .018”
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D746FRL4181PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)883-8733sales@essix.com

Regulatory Flags#

DUNS number
116903307
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D746EPOO4W1PonticEPOO4-WEPOO4-W2016-09-24
D746EPOO4Y1PonticEPOO4-YEPOO4-Y2016-09-24
D746RBTPC1RETAINER BRITE®RB-TP-CRB-TP-C2021-05-01
D746ELA6G1Lower Anterior PonticELA6-GELA6-G2016-09-24
D746ELA6W1Lower Anterior PonticELA6-WELA6-W2016-09-24
D746ELA6Y1Lower Anterior PonticELA6-YELA6-Y2016-09-24
D746EUT6W1Essix®EUT6-WEUT6-W2016-09-24
D746EUT6Y1Essix®EUT6-YEUT6-Y2016-09-24
D746PLMOG1Posterior Lower PonticPLMO-GPLMO-G2016-09-24
D746PLMOW1Posterior Lower PonticPLMO-WPLMO-W2016-09-24
D746PLMOY1Posterior Lower PonticPLMO-YPLMO-Y2016-09-24
D746PUMOG1Posterior Lower PonticPUMO-GPUMO-G2016-09-24
D746PUMOW1Posterior Lower PonticPUMO-WPUMO-W2016-09-24
D746PUMOY1Posterior Lower PonticPUMO-YPUMO-Y2016-09-24
D746SUA6W1Square Upper PonticSUA6-WSUA6-W2016-09-24
D746SUA6Y1Square Upper PonticSUA6-YSUA6-Y2016-09-24
D746TUA6G1EssixTUA6-GTUA6-G2016-09-24
D746TUA6W1EssixTUA6-WTUA6-W2016-09-24
D746TUA6Y1EssixTUA6-YTUA6-Y2016-09-24
D74640035BL1SpaceFile®40035-BL40035-BL2021-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D829665016200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665016200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665020200M0051Premium LineEC Certification Service GmbHDYW2026-05-28