FDA.report

Pomee

Primary DI
G15771090
Brand
Pomee
Company
POMEE CORPORATION
Model
7109
Catalog number
7109
Device description
Rectangular arch / ribbon arch plier
Published
2021-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
JEXPlier, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G15771090PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
645717646
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
G1577078150Pomee707-815707-8152023-10-18
G1577078170Pomee707-817707-8172023-10-18
G1577078200Pomee707-820707-8202023-10-18
G1577078250Pomee707-825707-8252023-10-18
G1577078300Pomee707-830 707-830 2023-10-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B382SD91427410030Surgical DirectSurgical Direct, Inc.JEX2026-02-09
B382SD9142761200Surgical DirectSurgical Direct, Inc.JEX2026-02-09
00190746065477Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746065507Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067426Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067440Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
10190707086494Triumph®Ortho Organizers, Inc.JEX2026-01-07
00190707086503Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086517Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086524Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086531Triumph®Ortho Organizers, Inc.JEX2026-01-07
D9098000041SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800022S1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063C1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063L1ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980007214ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980008417SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980008518SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980023515RAZOROrtho Arch Company IncJEX2025-09-15
D90980023919RAZOROrtho Arch Company IncJEX2025-09-15
D909800239T1RAZOROrtho Arch Company IncJEX2025-09-15
D90980024011RAZOROrtho Arch Company IncJEX2025-09-15
D90980024112RAZOROrtho Arch Company IncJEX2025-09-15
D90980024213RAZOROrtho Arch Company IncJEX2025-09-15
D9098002761ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002771ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002781ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002791ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980013817ORTHO ARCHOrtho Arch Company IncJEX2025-08-27
04963931274291NAYDM CORPORATIONJEX2025-07-11