FDA.reportPublic FDA data

ANALOG HE Ø4.1MM HEX. 2.85

Primary DI
07899995267979
Brand
ANALOG HE Ø4.1MM HEX. 2.85
Company
Sin Sistema de Implante Nacional S/A
Model
AN 4100EA
Catalog number
AN 4100EA
Device description
ANALOG HE Ø4.1MM HEX. 2.85
Published
2023-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
07899995267979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995267979078999952679797899995267979

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods#

Method table
Method

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

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