FDA.reportPublic FDA data

Premium Plus

Primary DI
D838CT3399090RB8
Brand
Premium Plus
Company
Premium Plus International Limited
Model
CT3399-090RB
Device description
Disposable Prophy Angles
Published
2020-01-02
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
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D838CT3399090RB8PackageHIBCC20In Commercial Distribution
D838CT3399090RB2PrimaryHIBCC0
D838CT3399090RB0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
668367758
Device count
100
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
D83848982Premium Plus48982020-01-08
D8384604Premium Plus4602019-12-27
D8384704Premium Plus4702019-12-27
D8387460B4Premium Plus7460-B2019-12-27
D8387460G4Premium Plus7460-G2019-12-27
D8387460L4Premium Plus7460-L2019-12-27
D8387460R4Premium Plus7460-R2019-12-27
D8387460Y4Premium Plus7460-Y2019-12-27
D8387470B4Premium Plus7470-B2019-12-27
D8387470G4Premium Plus7470-G2019-12-27
D8387470L4Premium Plus7470-L2019-12-27
D8387470R4Premium Plus7470-R2019-12-27
D8387470Y4Premium Plus7470-Y2019-12-27
D8389062Premium Plus9062019-12-26
D8389072Premium Plus9072019-12-26
D83832202Premium Plus32202020-01-08
D83832252Premium Plus32252020-01-08
D838033LBLUE2Premium Plus033-LBLUE2020-01-08
D8381140BEIGE2Premium Plus1140-BEIGE2020-01-07
D8381140BLUE2Premium Plus1140-BLUE2020-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079280069Turbo EdgeHexa DentalEGS2026-03-04
00850079280083Turbo EdgeHexa DentalEGS2026-03-04
20686864060943MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
20686864060950MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
00008579280083Turbo edgeHexa DentalEGS2026-01-21
00085007928069Turbo EdgeHexa DentalEGS2026-01-21
00850079280076Turbo EdgeHexa DentalEGS2026-01-21
00850079280090Turbo EdgeHexa DentalEGS2026-01-21
00850079280106Turbo EdgeHexa DentalEGS2026-01-21
00850079280113Ergo glideHexa DentalEGS2026-01-21
08404535020892Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020922Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020953Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020984Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535021738ForzaPeter Brasseler Holdings, LLCEGS2026-01-09
00304040194331Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194379Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
D745701120GLH00010Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00020Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00030Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D950135030SmoothdriveLARES RESEARCHEGS2025-08-25
06971119540548Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540586Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540593Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540982Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540999Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15