FDA.reportPublic FDA data

STERLING

Primary DI
00366975064059
Brand
STERLING
Company
BENCO DENTAL SUPPLY CO.
Model
5821-176
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EMMChisel, Osteotome, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975064059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975064059003669750640593669750640590366975064059

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

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13
D74419672861Gibson Healthcare1967-2861967-2862017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESAM13290011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333061STOMA®Storz am Mark GmbHEMM2020-08-27
10649111069406Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069710Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069765Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111070082Sklar®SKLAR CORPORATIONEMM2018-10-22