FDA.reportPublic FDA data

Enthus

Primary DI
00353045001793
Brand
Enthus
Company
DHARMA RESEARCH, INC.
Model
38-00003
Catalog number
38-00003
Device description
Enthus VPS Impression Material, Light Body, Regular Set, Spearmint Flavor, 4 x 50ml Cartridges
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K041028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041028000CROWN DELTA HYDROPHILIC IMPRESSION MATERIALCrown Delta Corp.2004-05-14ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10353045001790PackageGS112In Commercial Distribution
00353045001793PrimaryGS10
00353045002677Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500179010353045001790
00353045001793003530450017933530450017930353045001793
00353045002677003530450026773530450026770353045002677

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius23 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+3054829669rcarles@dharmaresearch.com
8778333725info@dharmaresearch.com

Regulatory Flags#

DUNS number
078444642
Device count
4
DM exempt
true
Kit
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
00353045000628Jade20-0000520-000052016-10-07
00353045000635Jade20-0000220-000022016-10-07
00353045000642Jade20-0000320-000032016-10-07
00353045000659Jade20-0000420-000042016-10-07
00353045000666Jade20-0000120-000012016-10-07
00353045000673Jade20-0000620-000062016-10-07
00353045000680Jade20-0000720-000072016-10-07
00353045000697Jade20-0000820-000082016-10-07
00353045000703Jade20-0000920-000092016-10-07
00353045002127Jade20-0001620-000162016-10-07
00353045002134Jade20-0009120-000912016-10-07
00353045000710Jade20-0001020-000102016-10-07
00353045002349Citrine56-0020056-002002016-10-07
00353045002356Citrine56-0020256-002022016-10-07
00353045002363Citrine56-0020456-002042016-10-07
10353045000625Jade20-0000520-000052016-10-07
10353045000632Jade20-0000220-000022016-10-07
10353045000649Jade20-0000320-000032016-10-07
10353045000656Jade20-0000420-000042016-10-07
10353045000663Jade20-0000120-000012016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
18016200021805KROMOPAN SIL MONO - monofase (2x50ml)LASCOD SPAELW2026-05-28
18016200021843KromopanSil Bite 2x50mlLASCOD SPAELW2026-05-28
18016200010298IQ - alginato non cromatico verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010496IQ TROPICAL - alginato cromatico tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
00850079280441HygedentUSAHexa DentalELW2026-01-12
00850079280465HygedentUSAHexa DentalELW2026-01-12
00850079280472HygedentUSAHexa DentalELW2026-01-12
00850079280489HYgedentUSAHexa DentalELW2026-01-12