FDA.reportPublic FDA data

Pomee

Primary DI
G1577048600
Brand
Pomee
Company
POMEE CORPORATION
Model
704-860
Catalog number
704-860
Device description
Explorer D.E #6
Published
2021-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
EIXProbe, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577048600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. 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
00850083275693Intrace USAPILOTIS TECH LLCEIX2026-07-03
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811885QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811892QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811908QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811915QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811922QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506839414QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506843862QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849239QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849253QuinelatoSchobell Industrial LtdaEIX2022-12-08
07899798200258QuinelatoSchobell Industrial LtdaEIX2022-12-08
10889950034726HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034733HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034757HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034764HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034771HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034788HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034795HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034801HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034832HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034849HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034856HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034863HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034870HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12
10889950034887HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIX2020-11-12