FDA.reportPublic FDA data

SDC impression material (Zest)

Primary DI
00850007728243
Brand
SDC impression material (Zest)
Company
Access Dental Lab, LLC
Model
200-0106
Device description
impression material used to create dental impressions
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
00850007728243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007728243008500077282438500077282430850007728243

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

Regulatory Flags#

DUNS number
054012763
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007728427SmileDirectClub Retainer 140-00042023-11-30
00850007728410ALIGNER SEATER PURPLE220-00052023-02-17
00850007728250SDC-impression material (Kulzer)200-01072023-02-17
00850007728342Smile stretcher-purple bag200-00492023-02-17
00850007728366Impression Tray XSM200-00112023-02-17
00850007728373IMPRESSION TRAY SM200-00122023-02-17
00850007728380IMPRESSION TRAY MED200-00132023-02-17
00850007728397IMPRESSION TRAY LRG200-00142023-02-17
00850007728403IMPRESSION TRAY XLG200-00152023-02-17
00850007728274SDC ALIGNERS MCC100-00102022-12-09
00850007728281SDC Aligners-REF100-00122022-12-09
00850007728298SDC Aligners-REP100-03552022-12-09
00850007728304NIGHTTIME CLEAR ALIGNERS100-03622022-12-09
00850007728311NIGHTTIME ALIGNERS-MCC100-03632022-12-09
00850007728328NIGHTTIME ALIGNERS - REF100-03642022-12-09
00850007728335NIGHTTIME -REP100-03652022-12-09
00850007728267SDC Aligners-100-03522022-12-07
00850007728052electric toothbrush100-03562019-08-14
00850007728069Electric Toothbrush100-03572019-08-14
00850007728076ElectricToothbrush100-03582019-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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18016200021744KROMOPAN SIL regular body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021751KROMOPAN SIL heavy body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021768KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
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