FDA.report

Pomee

Primary DI
G1577092550
Brand
Pomee
Company
POMEE CORPORATION
Model
709-255
Catalog number
709-255
Device description
Baade Plier Remover #225
Published
2022-01-04
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
G1577092550PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat 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

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