FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950004149
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
678-910
Catalog number
678-910
Device description
Dull H5/33 DE Scaler, Satin Steel Handle
Published
2020-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECPINSTRUMENT, LIGATURE TUCKING, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889950004149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995000414910889950004149

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(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14
08800012411052Hu-FriedySSC-URD42024-10-14
08800012411069Hu-FriedySSC-URD52024-10-14
08800012411076Hu-FriedySSC-URD62024-10-14
08800012411083Hu-FriedySSC-URD72024-10-14
08800012411090Hu-FriedySSC-LLD22024-10-14
08800012411106Hu-FriedySSC-LLD32024-10-14
08800012411113Hu-FriedySSC-LLD42024-10-14
08800012411120Hu-FriedySSC-LLD52024-10-14
08800012411137Hu-FriedySSC-LLD62024-10-14
08800012411144Hu-FriedySSC-LLD72024-10-14
08800012411151Hu-FriedySSC-LRD22024-10-14
08800012411168Hu-FriedySSC-LRD32024-10-14
08800012411175Hu-FriedySSC-LRD42024-10-14
08800012411274Hu-FriedySSC-URE22024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB1350TBS BASICSACME ENTERPRISE.ECP2026-05-18
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00840479203669SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-13
00840479203270MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203287MIXING RESERVOIR RING WELRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203348SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479203447SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-12
00840479202112MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202143MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202150MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479202167MIXING ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-10
00840479201528SYRINGE WING (1)RELIANCE ORTHODONTIC PRODUCTS INCECP2026-03-05
00840479200576SPATULARELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200583WHITE SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200590LIGHT IMPERVIOUS MIX WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200606SUPERFINE MICROBRUSHRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200651SPONGE PELLETRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
0084047920070521 GAUGE BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200712"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200729"4"" BEND A BRUSHES"RELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200743ACCESSORY PACKRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200972BRUSH TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-23
00840479200354WHITE MIXING WELLRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200361CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200385CLEAR SCOOPRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479200866BRUSH HANDLE ASSORTEDRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479203454SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
0084047920349215 GAUGE TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20
00840479209814SELF MIXING TIPSRELIANCE ORTHODONTIC PRODUCTS INCECP2026-02-20