FDA.reportPublic FDA data

Parallel Pin

Primary DI
08809918259966
Brand
Parallel Pin
Company
Ossvis Co., Ltd.
Model
HPP3523
Device description
Dental Implant Surgical Instrument - Parallel Pin
Published
2024-11-22
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
08809918259966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918259966088099182599668809918259966

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695365503
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
08809918274143LW Digital Lab Analog GMLWSDLAGM2026-04-20
08809918274150LW Narrow Dirigal Lab Analog GMLWNDLAGM2026-04-20
08809918274136Screw Remover TipHSRT2026-03-12
08809918274013LL Scan BodyLLMFSB2025-12-31
08809918259997LL Driver SeparatorHLLFRP2025-12-15
08809918274037Guide Full Flattening DrillHFD50GF2025-12-15
08809918274044Guide Full Lindemann DrillHLD1807GF2025-12-15
08809918274051Guide Full Lindemann DrillHLD1808GF2025-12-15
08809918274068Guide Full Lindemann DrillHLD1810GF2025-12-15
08809918274075Guide Full Lindemann DrillHLD1811GF2025-12-15
08809918274082Guide Full Lindemann DrillHLD1813GF2025-12-15
08809918274099Guide Full Cortical DrillHCD50GF2025-12-15
08809918274105Guide Full NoMount Driver EngineHNRSEGF2025-12-15
08809918274112Guide Full NoMount Driver EngineHNNRSEGF2025-12-15
08809918274129Guide Full Anchor Driver EngineHARSEGF2025-12-15
08809918274020LL Scan BodyLLMFSBPE2025-06-26
08809918209756LW Pre-milled AbutmentLWDPA1040HDB2024-12-18
08809918209763LW Pre-milled AbutmentLWDPA1040NDB2024-12-18
08809918209770LW Pre-milled AbutmentLWDPA1040HMX2024-12-18
08809918209787LW Pre-milled AbutmentLWDPA1040NMX2024-12-18

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