FDA.reportPublic FDA data

PRESS FORM SHEETS

Primary DI
00841494104290
Brand
PRESS FORM SHEETS
Company
Cynosure, LLC
Model
EPS352
Catalog number
EPS352
Device description
PRESS FORM SHEETS, SOFT, .080
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBLPIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494104290PrimaryGS10
00841494106348Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494104290008414941042908414941042900841494104290
00841494106348008414941063488414941063480841494106348

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
15
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060227046Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2026-02-10
00810060225967Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225974Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225981Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060225998Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226001Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226018Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226025Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
00810060226032Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2024-05-29
08800075620965OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
08800075620972OSUNG MNDOSUNG MND Co., Ltd.EBL2024-03-06
00810060225721Blue Sky Bio, LLC.BLUE SKY BIO LLCEBL2023-11-09
05060489370006StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370013StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370037StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370044StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370068StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370075StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370020StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
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05060489370174StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370051StabilokFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370204Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
05060489370198Stabilok drillFAIRFAX MEDICAL PRODUCTS LIMITEDEBL2023-04-16
D2483801802Markley Threaded Wire .018HAGER WORLDWIDE, INC.EBL2023-04-10
D248380220Markley Threaded Wire .022HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802500Markley Threaded Wire .025HAGER WORLDWIDE, INC.EBL2023-04-10
D2483802702Markley Threaded Wire .027HAGER WORLDWIDE, INC.EBL2023-04-10
D248380300Markley Threaded Wire .030HAGER WORLDWIDE, INC.EBL2023-04-10