FDA.reportPublic FDA data

Almore Microfil Instrument - Blue

Primary DI
D2489604315
Brand
Almore Microfil Instrument - Blue
Company
HAGER WORLDWIDE, INC.
Model
96043
Device description
Dental composite instrument, trims interproximally and shapes the facial surface of the tooth, Length 6-1/2"
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIKCARVER, WAX, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D2489604315Direct MarkingHIBCC0
00014081960436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00014081960436000140819604360140819604360014081960436

GMDN Terms#

Term, Definition table
TermDefinition
Dental wax carverA hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags#

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
D2486058701Hager Prophy Brush Fine Flat6058702026-05-12
D248938521Uni-Wedge Regular ( Orange)938522026-01-28
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2481009320"""Heidi"" Protective Eyewear "1009322025-10-22
D2481009330"""Ella"" Protective Eyewear "1009332025-10-22
D2481009350"""Lucy"" Protective Eyewear "1009352025-10-22
D2483552480BurButler (5-Hole Pink Base w/Lid)3552482025-10-22
D2483552490BurButler (5-Hole Purple Base w/Lid)3552492025-10-22
D2483552500BurButler (5-Hole White Base w/Lid)3552502025-10-22
D2483552510BurButler (5-Hole Blue Base w/Lid)3552512025-10-22
D2483552550BurButler (10-Hole Orange Base w/Lid)3552552025-10-22
D2483552570BurButler (10-Hole Black Base w/Lid)3552572025-10-22
D2483552580BurButler (10-Hole Purple Base w/Lid)3552582025-10-22
D2483552590BurButler (25-Hole White Base w/Lid)3552592025-10-22
D2483552610BurButler (25-Hole Purple Base w/Lid)3552612025-10-22
D2483552630BurButler (25-Hole Orange Base w/Lid)3552632025-10-22
D2483552640BurButler (25-Hole Black Base w/Lid)3552642025-10-22
D2483552650BurButler (25-Hole Orange Base w/ Tall Lid)3552652025-10-22
D2483552660BurButler (25-Hole Blue Base w/ Tall Lid)3552662025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB8100TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8110TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8120TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8140TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8150TBS BASICSACME ENTERPRISE.EIK2026-05-18
G149TBSB8050TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8060TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8070TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8160TBS BASICSACME ENTERPRISE.EIK2026-05-17
G149TBSB8170TBS BASICSACME ENTERPRISE.EIK2026-05-17
00348783010077Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-28
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00348783010060Premier Lab InstrumentsPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-27
00348783012309Premier CarversPREMIER DENTAL PRODUCTS COMPANYEIK2026-04-01
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
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00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
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