FDA.reportPublic FDA data

Pomee

Primary DI
G1577068500
Brand
Pomee
Company
POMEE CORPORATION
Model
706-850
Catalog number
706-850
Device description
Wedge-shaped gauge
Published
2023-10-11
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
EILGauge, Depth, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577068500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Interproximal dental gauge, reusableA device intended to be used in dentistry to measure the clearance between adjacent teeth (e.g., in orthodontic treatment during reproximation to relieve pressure points between teeth). The device is typically available in a set of stainless steel graduated gauges, typically with notches on the side to help with identification. Device thickness typically ranges from 0.1 mm to 0.5 mm. 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
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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J003SVN650901Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003VXSV620451Vortex Size VerifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J0036692981Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693001Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693011Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693021Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693031Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693041Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693051Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693061Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693071Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693081Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF11Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVAST1Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX21Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX31Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX41Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTNSVX51Protaper Next Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVAST1Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTUSVF11Protaper Universal Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26