FDA.reportPublic FDA data

COMFORT OCCLUSAL 4C ACCESSORY KIT

Primary DI
06430035873357
Brand
COMFORT OCCLUSAL 4C ACCESSORY KIT
Company
PaloDEx Group Oy
Model
900320-PTU
Catalog number
900320-PTU
Device description
COMFORT OCCLUSAL 4C ACCESSORY KIT
Published
2025-12-23
Public version status
New
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
06430035873357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035873357064300358733576430035873357

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging phosphor plate intraoral coverAn intraoral device in the form of an envelope or sleeve intended to cover a digital imaging phosphor plate prior to introduction into the oral cavity, to prevent cross-contamination between patients and/or shield the plate from ambient light. 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
06430035873371OCCLUSAL 4C KIT SCAN EXAM900801-DEX2026-06-22
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
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
00840456214459JMUJMU DENTAL, INCPEM2026-07-10
00840456214466JMUJMU DENTAL, INCPEM2026-07-10
00840456214473JMUJMU DENTAL, INCPEM2026-07-10
00840456214480JMUJMU DENTAL, INCPEM2026-07-10
00840456214497JMUJMU DENTAL, INCPEM2026-07-10
00840456214503JMUJMU DENTAL, INCPEM2026-07-10
00840456217931JMUJMU DENTAL, INCPEM2026-07-10
00840456217948JMUJMU DENTAL, INCPEM2026-07-10
00840456217955JMUJMU DENTAL, INCPEM2026-07-10
00840456217962JMUJMU DENTAL, INCPEM2026-07-10
00840456217979JMUJMU DENTAL, INCPEM2026-07-10
00840456217986JMUJMU DENTAL, INCPEM2026-07-10
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06