FDA.reportPublic FDA data

OptiClear Sleeves

Primary DI
B9764488101
Brand
OptiClear Sleeves
Company
Minitube AB
Model
448806
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
OTC
false
Sterile
false
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
B9764488001PrimaryHIBCC0
B9764488041PrimaryHIBCC0
B9764488061PrimaryHIBCC0
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
775295061
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9764488001OptiClear Sleeves4488002026-02-13
B9764488041OptiClear Sleeves4488042026-02-13
B9764488061OptiClear 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
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