FDA.report

CURETTE MONTANA JACK HF HANDLE

Primary DI
D928705164HTIN0
Brand
CURETTE MONTANA JACK HF HANDLE
Company
W.H. Holden, Inc.
Model
70-5164HTIN
Published
2023-12-20
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

Related Records

Product Codes

CodeName
EMSCURETTE, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D928705164HTIN0PrimaryHIBCC0

GMDN Terms

TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
183854322
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
D9281051992HF0SINUS INSTRUMENT #2 HF D/E10-5199-2HF2026-02-19
D928400527H0POWERTOME S/E HF HANDLE40-0527H2026-01-27
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE10-6122-R452026-01-15
D9281059552HF570CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG10-5955-2HF572026-01-14
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLE40-0101CH2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLE40-0102CH2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE40-0102R2026-01-14
D9284001040D928400104040-01042026-01-14
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLC10-0600-962DLC2026-01-06
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM10-0930-18-52026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MM10-0930-23-62026-01-06
D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLC10-5106HDHF-DLC2026-01-06
D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLC10-5109JHF59DLC2026-01-06
D928105402HF0PERIOSTEAL ELEVATOR LANGER, MIRROR FINISH, HF D/E10-5402HF2026-01-06
D928105410CH0PERIOSTEAL ELEVATOR HOWARD #9H CH D/E10-5410CH2026-01-06
D928105488CHDLC0PERIOSTEAL ELEVATOR WOODSON SPEAR AND PERIO KNIFE, CH D/E DLC10-5488CHDLC2026-01-06
D928105489RK0PERIOSTEAL ELEVATOR, MODIFIED BUSER, ROUND KNURLED HANDLE, D/E10-5489RK2026-01-06
D928105490R0CURETTE, MODIFIED MOLT 2CH / 4HD, ROUND HANDLE, D/E10-5490R2026-01-06
D9281055350"OH" ZYGOMA RETRACTOR10-55352026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783007466Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007473Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007534Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007541Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007558Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007565Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007572Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007596Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007602Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007619Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007671Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007756Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008159Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008166Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008173Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008197Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008210Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008227Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008234Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008241Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008258Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00840018674547Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674554Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674561Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674493Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
00840018674509Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
04251436943843KOHLERKohler Medizintechnik GmbHEMS2026-03-12
00840018674295Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11