FDA.reportPublic FDA data

RONGEUR #10S MINI FRIEDMAN, 2.5CM, 30 DEGREE, 14 CM DLC

Primary DI
D9284232014DLC0
Brand
RONGEUR #10S MINI FRIEDMAN, 2.5CM, 30 DEGREE, 14 CM DLC
Company
W.H. Holden, Inc.
Model
42.320.14DLC
Published
2025-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMHForceps, Rongeur, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9284232014DLC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183854322
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9282000201SUL0SMITH SAGGITAL SPLITTER-MOD20-0020-1-SUL2026-05-27
D928105406HFDLC0STAHR TUNNEL RETRACTOR HF D/E DLC10-5406HFDLC2026-03-18
D928105535DLC0"""OH"" ZYGOMA RETRACTOR DLC"10-5535DLC2026-03-18
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN40-0400-1CH2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN40-0400-2CH2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE40-0400CH2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE40-0400HD2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE40-0400HF2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE40-0435RD2026-03-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955RON811S1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONBLU1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONMC0Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
B76884850220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-05
B7685631130Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688371010Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688386020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884751040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884754320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
B7688457751630Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
B7688457751030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-21
B76884332520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-13
B7688452420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-03
B76884850320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B7685636870Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B7685636880Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B76884342320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-06-20
B76884342420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-06-20
B7688365450Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-23
B7688439220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-23
B7685638140Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-20
B7688378040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-20
B7688457651620Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-07