FDA.reportPublic FDA data

Pomee

Primary DI
G1577083100
Brand
Pomee
Company
POMEE CORPORATION
Model
708-310
Catalog number
708-310
Device description
"Articulting Paper Forceps 6"" Curved & Serrated "
Published
2022-01-04
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
EFKForceps, Articulation Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFKForceps, Articulation PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577083100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paper forcepsA hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam 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
G149TBSB4290TBS BASICSACME ENTERPRISE.EFK2026-05-21
00889813066553Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFK2024-11-30
00813677022486PDT, Inc.PDT, INC.EFK2024-07-01
00842517103924Karl SchumacherKarl Schumacher Dental, LLCEFK2024-02-27
08800075603579OSUNG MNDOSUNG MND Co., Ltd.EFK2024-02-19
08964003163488NivoB. Ali ImpexEFK2024-01-29
08964003163662PREHMAB. Ali ImpexEFK2024-01-29
00310866002590NANOBYTEPASCAL COMPANY, INC.EFK2023-11-29
D040603000Forceps- PaperWHIP-MIX CORPORATIONEFK2023-08-18
07898506812141QuinelatoSchobell Industrial LtdaEFK2022-12-08
00887919408963Brasseler USAPeter Brasseler Holdings, LLCEFK2022-12-08
EZPF22100150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
EZPF22101150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
04963931270668NAYDM CORPORATIONEFK2022-09-30
04963931270675NAYDM CORPORATIONEFK2022-09-30
D77370010500Health-Tec/DHP Hand InstrumentsDental Health Products IncEFK2022-09-28
00850043381174Buffalo Dental MfgBuffalo Dental Manufacturing Co., Inc.EFK2022-08-05
00366975051059BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
00366975051066BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
G1577083000PomeePOMEE CORPORATIONEFK2022-01-04
G1577083050PomeePOMEE CORPORATIONEFK2022-01-04
D701ARPH2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D701ARPS2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D72310296083Safco Articulating Paper ForcepsSAFCO DENTAL SUPPLY CO.EFK2021-07-01
00840105217466ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217473ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217503ZOLL-DENTALZoll-DentalEFK2021-03-10
10889950004323HU-FRIEDYHU-FRIEDY MFG. CO., LLCEFK2020-11-12
10889950041489HU-FRIEDYHU-FRIEDY MFG. CO., LLCEFK2020-11-12
04560218667120DENTECHDENTECH CORPORATIONEFK2020-09-24