FDA.reportPublic FDA data

Posterior Lower Pontic

Primary DI
D746PLMOG1
Brand
Posterior Lower Pontic
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
PLMO-G
Catalog number
PLMO-G
Device description
Posterior Lower Pontic Set - Gray
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
ELMDenture, plastic, teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D746PLMOG1PrimaryHIBCC0
D746PLMOG0Unit 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
+1(844)848-0137essix.sales@dentsplysirona.com

Regulatory Flags#

DUNS number
116903307
Device count
8
DM exempt
true
Premarket 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
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
D746848FD1N/A848FD848FD2021-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
07630813462639TCR MultiCandulor AGELM2026-07-28
07630813462646TCR MultiCandulor AGELM2026-07-28
07630813462653TCR MultiCandulor AGELM2026-07-28
07630813462660TCR MultiCandulor AGELM2026-07-28
07630813462677TCR MultiCandulor AGELM2026-07-28
07615208592634Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592689Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592696Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592702Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592719Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
E235DPCS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPOMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPSGS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPTIS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03