FDA.reportPublic FDA data

BITE BLOCK (SET OF 10 PCS)

Primary DI
06430035874453
Brand
BITE BLOCK (SET OF 10 PCS)
Company
PaloDEx Group Oy
Model
203214
Published
2021-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHAAligner, Beam, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHAAligner, Beam, X-RayDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092591000ORTHOPANTOMOGRAPH OP30Instrumentarium Dental, Palodex Group OY2009-11-20MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035874453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035874453064300358744536430035874453

GMDN Terms#

Term, Definition table
TermDefinition
Seizure bite blockA non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
459955188
Device count
1
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
06430035873357COMFORT OCCLUSAL 4C ACCESSORY KIT900320-PTU900320-PTU2025-12-23
06430035873388OCCLUSAL 4C REFILL KIT900802-DEX2025-12-23
06430035875191ORTHOPANTOMOGRAPH™ OP 3DPCX-1901308-PTU2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D090101399140DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEHA2026-08-03
D003B01200001SchickDentsply International Inc.EHA2024-11-06
D003B01210001SchickDentsply International Inc.EHA2024-11-06
D003B10731001UniversalDentsply International Inc.EHA2024-11-06
D003B01200000SchickDentsply International Inc.EHA2024-11-06
D003B01210000SchickDentsply International Inc.EHA2024-11-06
D003B01220001SchickDentsply International Inc.EHA2024-11-06
D003B10731000UniversalDentsply International Inc.EHA2024-11-06
D003B10731101AimRightDentsply International Inc.EHA2024-11-06
D003B24041001SchickDentsply International Inc.EHA2024-11-06
D003B24042001SchickDentsply International Inc.EHA2024-11-06
D7641000053341AimRightSIRONA DENTAL, INC.EHA2022-12-07
D764B02100001Intraoral Sensor Holders Arms and Rings SIRONA DENTAL, INC.EHA2022-12-07
D764B10731001Intraoral Sensor Holder Arms and RingsSIRONA DENTAL, INC.EHA2022-12-07
D764B10740501AimRight HolderSIRONA DENTAL, INC.EHA2022-12-07
D090082251290Endodontic Bar - Alignment BarDental Imaging Technologies CorporationEHA2022-12-06
D090086000360Bar, Alignment, Bitewing, DEXISDental Imaging Technologies CorporationEHA2022-12-06
D090086000370Bar, Alignment, UniversalDental Imaging Technologies CorporationEHA2022-12-06