FDA.reportPublic FDA data

Pomee

Primary DI
G15775500090
Brand
Pomee
Company
POMEE CORPORATION
Model
755-0009
Catalog number
755-0009
Device description
"Anterior Bracket Placer 4 1/4"" "
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
JEXPlier, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G15775500090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-ligating orthodontic bracket open/close toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags#

DUNS number
645717646
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G1577206B0Pomee7206-B7206-B2026-04-18
G15773010Pomee730173012026-04-18
G15773020Pomee730273022026-04-18
G15773030Pomee730373032026-04-18
G157PCAD0PomeePCADPCAD2026-04-18
G1577078910Pomee707-891707-8912025-06-14
G1577078920Pomee707-892707-8922025-06-14
G157PCAH0PomeePCAHPCAH2024-07-05
G157PCAP0PomeePCAPPCAP2024-07-05
G157PCAT0PomeePCATPCAT2024-07-05
G157PCAV0PomeePCAVPCAV2024-07-05
G1577025400Pomee702-540702-5402023-10-18
G1577025450Pomee702-545 702-5452023-10-18
G1577025500Pomee702-550702-5502023-10-18
G1577072950Pomee707-295707-2952023-10-18
G1577073000Pomee707-300707-3002023-10-18
G1577073050Pomee707-305707-3052023-10-18
G1577073100Pomee707-310707-3102023-10-18
G1577078100Pomee707-810707-8102023-10-18
G1577078120Pomee707-812707-8122023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791031420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791031430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050810DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G879105085M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050890DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050990DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051390DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910513910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051530DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910515910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791052160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791052280DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791053010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791053020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791053030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14