FDA.reportPublic FDA data

BAUER GUARDED OSTEO 4MM CRV

Primary DI
D9282000144C0
Brand
BAUER GUARDED OSTEO 4MM CRV
Company
W.H. Holden, Inc.
Model
20-0014-4C
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

Product Codes#

Code, Name table
CodeName
EMLCHISEL, BONE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9282000144C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be 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
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 DI, Brand, Model table
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

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Primary DI, Brand, Company table
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00840018661233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
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00194613013462MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
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00888912126991DJO SURGICALEncore Medical, L.P.EML2024-08-22
00888912127028DJO SURGICALEncore Medical, L.P.EML2024-08-22
00887482050606Symmetry Surgical®SYMMETRY SURGICAL INC.EML2024-08-12
00813677023254PDT, Inc.PDT, INC.EML2024-07-01
00813677023261PDT, Inc.PDT, INC.EML2024-07-01
00888912088725DJO SURGICALDJO, LLCEML2024-05-20
00842517105652Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06
00842517105669Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06