FDA.reportPublic FDA data

ANA Glass Cap Applicator

Primary DI
00853383006707
Brand
ANA Glass Cap Applicator
Company
Wykle Research, Inc
Model
1800000
Published
2018-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140993000IONOSTAR MOLARVoco GmbH2014-10-20EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853383006707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853383006707008533830067078533830067070853383006707

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614557155
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853383006738Wykle Wedges Assorted Sizes 500 count7002016-09-23
00853383006745Wykle Wedges 11mm Natural Color 500 count7112016-09-23
00853383006752Wykle Wedges 13mm Yellow Color 500 count7132016-09-23
00853383006769Wykle Wedges 15mm Blue Color 500 count7152016-09-23
00853383006776Wykle Wedges 17mm Green Color 500 count7172016-09-23
00853383006011Original D Capsules 1 Spill Fast Set 50 count61143-032016-09-23
00853383006158Original D Tablets Fast Set 10 oz174-102016-09-23
00853383006202Original D Capsules 2 Spill Fast Set 100 count61240-032016-09-23
00853383006035Wykalloy Capsules 1 Spill 50 count730002016-09-23
00853383006042Wykalloy Capsules 2 Spill 50 count731002016-09-23
00853383006059Wykalloy Capsules 3 Spill 50 count732002016-09-23
00853383006066Wykalloy Capsules 1 Spill 500 count733002016-09-23
00853383006073Wykalloy Capsules 2 Spill 500 count734002016-09-23
00853383006417Wykalloy amalgam sample pack759012016-12-14
00853383006523ANA 70 Powder 30g11100002018-04-13
00853383006547ANA 70 Powder 250g11102002018-04-13
00853383006554ANA 70 Duett 20011161002018-04-13
00853383006578ANA 70 Powder 500g11103002018-04-13
00853383006585ANA 70 Duett 5011181002018-04-13
00853383006608ANA 70 Duett 40011160002018-04-13

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