FDA.reportPublic FDA data

Pomee

Primary DI
G1577012150
Brand
Pomee
Company
POMEE CORPORATION
Model
701-215
Catalog number
701-215
Device description
Amalgam Condensers And Pluggers Smooth tips Blk #0/1
Published
2021-12-23
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

Product Codes#

Code, Name table
CodeName
EKGCondenser, Amalgam And Foil, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577012150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018672307Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-11
00840018670365Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671867Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671904Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018666092Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-09
00840018662506Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018663275Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018661325Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661769Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661936Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
05010058178106InstrapacROBINSON HEALTHCARE LIMITEDEKG2025-06-23
00889813065976Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-12-12
00889813065952Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065969Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065983Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813065990Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066003Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066027Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066034Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-11-30
00889813066010Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-10-01
00842517118553Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118560Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118577Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118584Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
00842517118591Karl SchumacherKarl Schumacher Dental, LLCEKG2024-05-06
08800075604668OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075604675OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609670OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
08800075609717OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04