FDA.reportPublic FDA data

EMULATE

Primary DI
D74439047781
Brand
EMULATE
Company
BENCO DENTAL SUPPLY CO.
Model
3904-778
Device description
EMULATE ADVANCED FAST SET 20#
Published
2017-02-13
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072245000EMULATE ADVANCEDCavex Holland BV2007-11-08ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D74439047781PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
015108087
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13
D74419672861Gibson Healthcare1967-2861967-2862017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800024205816Delikit 7.0 Light Body FastSherpakoreaELW2023-01-16
08800024205908Delikit 7.0 Extra Light Body FastSherpakoreaELW2023-01-16
08800024204420Delikit 7.0 Light Body RegularSherpakoreaELW2023-01-12
08800024204451Delikit 3.0 Light BodySherpakoreaELW2023-01-12
08800024204468Delikit 3.0 Light Body FastSherpakoreaELW2023-01-12
08800024204475Delikit 3.0 Extra Light Body FastSherpakoreaELW2023-01-12
08800024205397Delikit Putty Eco Fast SetSherpakoreaELW2023-01-12
08800024203805Delikit 3.0 Light BodySherpakoreaELW2022-09-15
08800024203997Delikit 3.0 Light Body FastSherpakoreaELW2022-09-15
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27
07640181479054AFFINISColtène/Whaledent AGELW2022-03-27
07640181479061AFFINISColtène/Whaledent AGELW2022-03-27
07640181479115AFFINISColtène/Whaledent AGELW2022-03-27
07640181479146AFFINISColtène/Whaledent AGELW2022-03-27
07640181479153AFFINISColtène/Whaledent AGELW2022-03-27
07640181479160AFFINISColtène/Whaledent AGELW2022-03-27
07640181479177AFFINISColtène/Whaledent AGELW2022-03-27
07640181479214AFFINISColtène/Whaledent AGELW2022-03-27
07640181479238AFFINISColtène/Whaledent AGELW2022-03-27
07640181479245AFFINISColtène/Whaledent AGELW2022-03-27
07640181479290AFFINISColtène/Whaledent AGELW2022-03-27
07640181479306AFFINISColtène/Whaledent AGELW2022-03-27
07640181479313AFFINISColtène/Whaledent AGELW2022-03-27