Dental Basics

Primary DI
00850061028020
Brand
Dental Basics
Company
Dental Basics Inc.
Model
BE10
Device description
Phosphor Plate Barrier Envelopes, Size 0, Side Opening
Published
2024-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K163447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163447000Premium Plus Disposable Barrier SleevePremium Plus International Limited2017-06-20PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850061028024PrimaryGS10
00850061028020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085006102802420850061028024
00850061028020008500610280208500610280200850061028020

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassetteA device used in medical imaging applications to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system and a computed radiography scanner, in the process of producing a digital image of a patient radiation pattern.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119194176
Device count
100
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850061028024Dental BasicsBE102024-05-08
00850061028006Dental BasicsBE212024-05-08
00850061028013Dental BasicsBE222024-05-08
00850061028037Dental BasicsBE112024-05-08
00850061028044Dental BasicsBE122024-05-08
00850061028051Dental BasicsBE202024-05-08
00850061028068Dental BasicsMA102024-05-08
00850061028075Dental BasicsMA112024-05-08
00850061028082Dental BasicsMA122024-05-08
00850061028099Dental BasicsMA132024-05-08
00850061028105Dental BasicsMA202024-05-08
00850061028112Dental BasicsMA212024-05-08
00850061028129Dental BasicsMA222024-05-08
00850061028136Dental BasicsAW102024-05-08
00850061028167Dental BasicsPA112024-05-08
00850061028174Dental BasicsPA122024-05-08
00850061028181Dental BasicsPA132024-05-08
00850061028198Dental BasicsPA142024-05-08
00850061028204Dental BasicsPA152024-05-08
20850061028000Dental BasicsBE212024-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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