FDA.reportPublic FDA data

Comfort Occlusal Hygiene Bags for occlusal projection images, size 4C, 100 PCS

Primary DI
06430035873326
Brand
Comfort Occlusal Hygiene Bags for occlusal projection images, size 4C, 100 PCS
Company
PaloDEx Group Oy
Model
900606
Published
2020-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133231000DIGORA OPTIMEInstrumentarium Dental, Palodex Group OY2014-03-20MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035873326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035873326064300358733266430035873326

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-use, non-sterileA non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
459955188
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035874637Imaging Plates901256-PTU2024-02-22
06430035874644Imaging Plates901257-PTU2024-02-22
06430035874651Imaging Plates901258-PTU2024-02-22
06430035874668Imaging Plates901259-PTU2024-02-22
06430035874675Imaging Plates901248-PTU2024-02-22
06430035874682Imaging Plates901249-PTU2024-02-22
06430035874699Imaging Plates901250-PTU2024-02-22
06430035874705Imaging Plates901251-PTU2024-02-22
06430035874996Imaging Plates901244-PTU2024-02-22
06430035875009Imaging Plates901245-PTU2024-02-22
06430035875016Imaging Plates901246-PTU2024-02-22
06430035875023Imaging Plates901247-PTU2024-02-22
06430035875030Imaging Plates901252-PTU2024-02-22
06430035875047Imaging Plates901253-PTU2024-02-22
06430035875054Imaging Plates901254-PTU2024-02-22
06430035875061Imaging Plates901255-PTU2024-02-22
06430035873357COMFORT OCCLUSAL 4C ACCESSORY KIT900320-PTU900320-PTU2025-12-23
06430035873388OCCLUSAL 4C REFILL KIT900802-DEX2025-12-23
06430035875191ORTHOPANTOMOGRAPH™ OP 3DPCX-1901308-PTU2025-07-15
06430035875184ORTHOPANTOMOGRAPH™ OP 3DPCX-1901307-PTU2025-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9764488001OptiClear SleevesMinitube ABPEM2026-02-13
B9764488041OptiClear SleevesMinitube ABPEM2026-02-13
B9764488061OptiClear SleevesMinitube ABPEM2026-02-13
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
00618125187126VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187133VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187140VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188710VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188727VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188734VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125189953VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190171VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190188VALOTIDI PRODUCTS, LLCPEM2025-08-29
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
10304040186722AccleanHENRY SCHEIN, INC.PEM2024-10-02
00816577024581Young InfinityYoung Innovations, Inc.PEM2024-09-30
00816577024604DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024611DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024628DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024635DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
20850061028024Dental BasicsDental Basics Inc.PEM2024-05-08
10371347011941Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
10371347011958Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
00816419021617iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021624iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021853iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021860iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021877iSmileIsmile Dental Products, Inc.PEM2023-06-21