FDA.reportPublic FDA data

Essix

Primary DI
D7461MEDL1201
Brand
Essix
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
1MEDL120
Catalog number
1MEDL120
Device description
3mm Essix Dual Laminate 120mm Circle
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN
KMYPOSITIONER, TOOTH, PREFORMED
MQCMouthguard, prescription
NXCAligner, sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
KMYPositioner, Tooth, PreformedDental1
MQCMouthguard, PrescriptionUnknownU
NXCAligner, SequentialDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062828000MOUTHGUARD AND ALIGNER MATERIALSDentsply Intl., Inc.2006-11-27MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7461MEDL1201PrimaryHIBCC0
D7461MEDL1200Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant template, radiographicA non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
116903307
Device count
50
DM exempt
true
Lot or batch
true
Manufacturing 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
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06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
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06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
00850004223307CandidProCANDID CARE CO.NXC2026-09-04
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08054154160044EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154160068EQULIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154160082EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154160242EQUILIBRATORE C4PEPTAMED SRLKMY2026-08-27
08054154161041EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161058EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161065EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27