FDA.reportPublic FDA data

Pomee

Primary DI
G1577121460
Brand
Pomee
Company
POMEE CORPORATION
Model
712-146
Catalog number
712-146
Device description
RDC #26 Slightly reversed festooned jaws for small lower molars.
Published
2021-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G1577121460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clampA dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645717646
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G1577078150Pomee707-815707-8152023-10-18
G1577078170Pomee707-817707-8172023-10-18
G1577078200Pomee707-820707-8202023-10-18
G1577078250Pomee707-825707-8252023-10-18
G1577078300Pomee707-830 707-830 2023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840456203835JMUJMU DENTAL, INCEIE2025-12-22
00840456203842JMUJMU DENTAL, INCEIE2025-12-22
07630392912112HySolateDent4You AGEIE2025-12-18
17630392912126HySolateDent4You AGEIE2025-12-18
17630392912133HySolateDent4You AGEIE2025-12-18
D990SD10PK0Silicone Dam 10PKSmart Denture Conversions, LLCEIE2025-05-19
00359883001353True™ Dental Dam Latex Free 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001360True™ Dental Dam Latex Free 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001377True™ Dental Dam Latex Free 5x5 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001384True™ Dental Dam Latex 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001391True™ Dental Dam Latex 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001407True™ Dental Dam Latex 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001414True™ Dental Dam Latex 5x5 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001438True™ Dental Dam Latex Free 6x6 Heavy SampleDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001445True™ Dental Dam Latex 6x6 Sample PackDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006648True™ Dental Dam Latex Free 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006679EdgeDam™ Refill Heavy 5x5 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006686EdgeDam™ Refill Heavy 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006693EdgeDam™ Refill Heavy 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006709EdgeDam™ Refill Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006716EdgeDam™ Refill Medium 5x5 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006723EdgeDam™ Refill Medium 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006730EdgeDam™ Refill Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006747EdgeDam™ Refill Medium 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006754EdgeDam™ Sample Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006761EdgeDam™ Sample Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
06972902583537C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2025-01-23