FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336111288
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
RAPID-ROLL
Catalog number
RAPID-ROLL
Device description
Salvin Rapid-Roll Covers
Published
2025-11-11
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
NRUCHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336108554PackageGS125In Commercial Distribution
00841336111288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336108554008413361085548413361085540841336108554
00841336111288008413361112888413361112880841336111288

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
113344790
Device count
1
Premarket exempt
true
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
00841336111905Allo-3D-PlusALLO-3D-PLUS-1.0ALLO-3D-PLUS-1.02024-07-11
00841336111912Allo-3D-PlusALLO-3D-PLUS-2.0ALLO-3D-PLUS-2.02024-07-11
00841336138766Salvin Dental SpecialtiesOFIBER-0.5CCOFIBER-0.5CC2025-09-28
00841336138773Salvin Dental SpecialtiesOFIBER-1.0CCOFIBER-1.0CC2025-09-28
00841336138797Salvin Dental SpecialtiesOFIBER-PLUS-0.5CCOFIBER-PLUS-0.5CC2025-09-28
00841336138803Salvin Dental SpecialtiesOFIBER-PLUS-1.0CCOFIBER-PLUS-1.0CC2025-09-28
00841336114395Salvin Dental SpecialtiesDEMIN-CORT-L-5.0DEMIN-CORT-L-5.02024-12-11
00841336125704Salvin Dental SpecialtiesSALVINOSS-0.5SALVINOSS-0.52024-12-11
00841336125711Salvin Dental SpecialtiesSALVINOSS-1.0SALVINOSS-1.02024-12-11
00841336125728Salvin Dental SpecialtiesSALVINOSS-2.5SALVINOSS-2.52024-12-11
00841336125735Salvin Dental SpecialtiesSALVINOSS-COLL-100MGSALVINOSS-COLL-100MG2024-12-11
00841336125759Salvin Dental SpecialtiesSALVINOSS-COLL-250MGSALVINOSS-COLL-250MG2024-12-11
00841336136229Salvin Dental SpecialtiesMIN-CAN-2.00MIN-CAN-2.002024-12-11
00841336138780Salvin Dental SpecialtiesOFIBER-2.5CCOFIBER-2.5CC2024-12-11
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10817417021408AsepticoASEPTICO, INC.NRU2026-10-13
00841709108860MidmarkMIDMARK CORPORATIONNRU2026-09-29
00841709108877MidmarkMIDMARK CORPORATIONNRU2026-09-29
00841709108884MidmarkMIDMARK CORPORATIONNRU2026-09-29
10194665008918A-decA-DEC, INC.NRU2026-06-22
D125780MLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780MW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SLB2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
D125780SW2Premium PlusPremium Plus (Dongguan) LimitedNRU2026-05-27
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151051Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151061Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151071Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151081Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151741Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151881Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09