FDA.reportPublic FDA data

OSTEOTOME N 1

Primary DI
07899995254498
Brand
OSTEOTOME N 1
Company
Sin Sistema de Implante Nacional S/A
Model
OST 01
Catalog number
OST 01
Device description
OSTEOTOME N 1
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995254498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995254498078999952544987899995254498

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
904569092
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995279668Abutment ScrewPRH 30 PACK4PRH 30 PACK42026-03-13
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23
07899995243812DRIVER RATCHET HEX1.4 LONG ANG.CCH 1430ACCH 1430A2025-12-23
07899995243829DRIVER RATCHET HEX1.4 MEDIUM ANG.CCH 1424ACCH 1424A2025-12-23
07899995243836DRIVER RATCHET HEX1.4 SHORT ANG.CCH 1420ACCH 1420A2025-12-23
07899995243843DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.CTH 1437ACTH 1437A2025-12-23
07899995243850DRIVER HANDPIECE HEX.1.4MM LONG ANG.CTH 1430ACTH 1430A2025-12-23
07899995243874DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.CTH 1424ACTH 1424A2025-12-23
07899995243881DRIVER HANDPIECE HEX.1.4MM SHORT ANG.CTH 1420ACTH 1420A2025-12-23
07899995240507DIRECTION INDICATOR ANGLED 52°IDA 52IDA 522025-11-26
07899995241108BioHorizonsZPK4500ZPK45002025-11-25
07899995243140BioHorizonsZPMDZPMD2025-11-25
07899995243157BioHorizonsZDPZDP2025-11-25
07899995243164BioHorizonsSTW80STW802025-11-25
07899995243225BioHorizonsHD050RHD050R2025-11-25
07899995243232BioHorizonsHD050MHD050M2025-11-25
07899995243263BioHorizonsHD050HHD050H2025-11-25
07899995243270BioHorizonsCRTRY60CRTRY602025-11-25
07899995243287BioHorizonsCRTRY52CRTRY522025-11-25
07899995243294BioHorizonsCRTRY45CRTRY452025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03