FDA.reportPublic FDA data

Pomee

Primary DI
G1577047650
Brand
Pomee
Company
POMEE CORPORATION
Model
704-765
Catalog number
704-765
Device description
Excavator Glick #2 spoon
Published
2021-12-29
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
EMKCurette, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577047650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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
B382SD9143681000Surgical DirectSurgical Direct, Inc.EMK2026-07-13
00850083275532Intrace USAPILOTIS TECH LLCEMK2026-07-03
00841336106413Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2026-06-08
G149TBSB7900TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7910TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7920TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7930TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7940TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7950TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149NP380620NPSACME ENTERPRISE.EMK2026-05-01
G149NPSCL0NPSACME ENTERPRISE.EMK2026-05-01
10889950126339Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126407Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
00348783007770Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007787Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007794Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007800Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007817Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007824Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007848Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00192896122444Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2025-10-28
00192896119758Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2024-09-05