FDA.reportPublic FDA data

SmileSet Impression Kit

Primary DI
00850078989338
Brand
SmileSet Impression Kit
Company
Ortho Dental Lab LLC
Model
110-0101
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000629000
K092319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000629000FLEXTIMEHeraeus Kulzer, Inc.2000-04-05ELW
K092319000STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387Danville Materials, Inc.2009-09-16ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078989338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078989338008500789893388500789893380850078989338

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material kit, single-useA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-604-7052support@smileset.com

Regulatory Flags#

DUNS number
119338749
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078989369SmileSet Impression Kit - Retainer110-01032026-03-20
00850078989376SmileSet Impression Kit - Night Guard110-01022026-03-20
00850078989154SmileSet Premium Whitening Refill – 4 Pack150-01222025-09-25
00850078989161SmileSet Premium Whitening Sample Pen – 3 ml150-01232025-09-25
00850078989352SmileSet Cheek Retractor200-01192025-10-16
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus Light150-01412025-10-16
00860012825523SmileDirectClub Dissolving Strips130-01012025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus Light150-01422025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 Pack130-01022025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 Pack150-01432025-10-16
00860012825578SmileDirectClub Water Flosser - White150-01442025-10-16
00860012825585SmileDirectClub Water Flosser - Black150-01452025-10-16
00860014476143SmileSet Aligner/Retainer Seater/Removal Tool221-0100 2025-10-16
00850078989284SmileSet Premium Floss Picks Mint – 10 Pack Samples150-01352025-10-01
00850078989291SmileSet Premium Floss Picks Mint – 50 Pack150-01362025-10-01
00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 Pack221-01012025-10-01
00850078989109SmileSet Sonic Toothbrush Refill Heads - Black with Mint150-01212025-09-25
00850078989116SmileSet Sonic Toothbrush Refill Heads - White with Mint150-01182025-09-25
00850078989123SmileSet Premium Whitening Kit – Black150-01192025-09-25
00850078989130SmileSet Premium Whitening Kit – Mint150-01202025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28