FDA.report

Pomee

Primary DI
G1577046030
Brand
Pomee
Company
POMEE CORPORATION
Model
704-603
Catalog number
704-603
Device description
Cleoid Discoid # 3/6 Large
Published
2023-09-26
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

Related Records

Product Codes

CodeName
EIKCarver, Wax, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G1577046030PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental restoration carver, resinA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
00840018666016Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-09
00840018663671Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665293Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665439Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665446Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018663305Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-29
00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00813677024145PDT, Inc.PDT, INC.EIK2024-06-27
00813677024152PDT, Inc.PDT, INC.EIK2024-06-27
00813677024169PDT, Inc.PDT, INC.EIK2024-06-27
00813677024176PDT, Inc.PDT, INC.EIK2024-06-27
00813677024183PDT, Inc.PDT, INC.EIK2024-06-27
00310866002644GET SCULPTEDPASCAL COMPANY, INC.EIK2024-05-16
00842517119352Karl SchumacherKarl Schumacher Dental, LLCEIK2024-05-06
08800075626479OSUNG MNDOSUNG MND Co., Ltd.EIK2024-03-06
08800075626516OSUNG MNDOSUNG MND Co., Ltd.EIK2024-03-06
08800075626486OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626493OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626509OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626523OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
G1577046890PomeePOMEE CORPORATIONEIK2023-10-16
G1577132500PomeePOMEE CORPORATIONEIK2023-10-11
G1577132700PomeePOMEE CORPORATIONEIK2023-10-11
G1577132750PomeePOMEE CORPORATIONEIK2023-10-11
G1577132770PomeePOMEE CORPORATIONEIK2023-10-11
G1577133030PomeePOMEE CORPORATIONEIK2023-10-11