FDA.reportPublic FDA data

Impla Clean Plastic Implant Instrument Kit

Primary DI
00014081552204
Brand
Impla Clean Plastic Implant Instrument Kit
Company
HAGER WORLDWIDE, INC.
Model
355220
Device description
Set of four double-ended plastic implant instruments. Each instrument is shaped differently.
Published
2023-03-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00014081552204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00014081552204000140815522040140815522040014081552204

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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
true
Premarket exempt
true
Kit
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
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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

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Primary DI, Brand, Company table
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