FDA.reportPublic FDA data

OptiClear Sleeves

Primary DI
B9764488041
Brand
OptiClear Sleeves
Company
Minitube AB
Model
448804
Device description
Disposable protective sheaths for intraoral cameras. Non-sterile. Single-use only.
Published
2026-02-13
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
K211026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211026000Minitube Dentasleeve Protective Barrier SleevesMinitube AB2021-08-03PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B9764488041PrimaryHIBCC0
B9764488101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
775295061
Device count
500
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9764488001OptiClear Sleeves4488002026-02-13
B9764488061OptiClear Sleeves4488062026-02-13
B9764488101OptiClear Sleeves4488062026-02-13
B9764488081OptiClear Sleeves4488082026-02-13
07350069421579C20 Intraoral Protective Sheaths4030622025-04-01
07350069421562C20 Intraoral Protective Sheaths4030612025-04-01
07350069420572C20 Intraoral Protective Sheaths4030622025-04-01
07350069421760MIXPAC Protective Sleeve50 mlPRS 801-032022-10-03
07350069421777MIXPAC Protective Sleeve5 mlPRS 701-032022-10-03
07350069421784MIXPAC Protective Sleeve1 mlPRS 601-032022-10-03
07350069421838VALO™ Barrier SleevesVALO Corded 600 Barrier Sleeves Refill 58972024-05-01
07350069421845VALO™ Barrier SleevesVALO X 600 Barrier Sleeves Refill58982024-05-01
07350069421852VALO™ Barrier SleevesVALO Cordless 600 Barrier Sleeves Refill 58962024-05-01
07649988629310OdneCleanA-0006A-00062024-06-01
07350069422835VALO™ Barrier SleevesVALO Corded 600 Barrier Sleeves Refill 58972024-05-01
07350069422842VALO™ Barrier SleevesVALO X 600 Barrier Sleeves Refill58982024-05-01
07350069422859VALO™ Barrier SleevesVALO Cordless 600 Barrier Sleeves Refill 58962024-05-01
07350069420763MIXPAC Protective Sleeve50 mlPRS 801-032022-10-03
07350069420770MIXPAC Protective Sleeve5 mlPRS 701-032022-10-03
07350069420787MIXPAC Protective Sleeve1 mlPRS 601-032022-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9764488001OptiClear 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
00816419021945iSmileIsmile Dental Products, Inc.PEM2023-06-21