FDA.reportPublic FDA data

Pomee

Primary DI
G1577073050
Brand
Pomee
Company
POMEE CORPORATION
Model
707-305
Catalog number
707-305
Device description
Tofflemire type matrix retainer contra angle child
Published
2023-10-18
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
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577073050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. 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
G1577073100Pomee707-310707-3102023-10-18
G1577078100Pomee707-810707-8102023-10-18
G1577078120Pomee707-812707-8122023-10-18
G1577078150Pomee707-815707-8152023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1380TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1420TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1430TBS BASICSACME ENTERPRISE.JEP2026-05-20
10304040193904Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193928Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193935Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
20686864061155MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10686864060649MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10686864060656MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10810038090495Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090501Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090518Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090525Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090532Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090549Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090556Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090563Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090492Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090508Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090515Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090522Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090539Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
M752ZZ14080STRADIS HEALTHCARESTRADIS MEDICAL, LLCJEP2022-04-29
10686864056482MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864056499MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10686864057151MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864057168MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10304040142803Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12
10304040142827Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12