FDA.reportPublic FDA data

Park Dental Research Corporation

Primary DI
D769BNC10
Brand
Park Dental Research Corporation
Company
PARK DENTAL RESEARCH CORP
Model
BNC-1
Catalog number
BNC-1
Device description
Bone Caliper
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
D769BNC10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dental device intended for use in denture fabrication to record the relative position of the maxillary arch to the temporomandibular joint (TMJ), or the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator and thereby aiding correct placement of artificial teeth into a denture base. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-243-7372sales@pdrus.com

Regulatory Flags#

DUNS number
011441508
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D769SVKIT0IMTEC SVKIT2026-04-28
D769IMSVKITMT0IMTEC IM-SVKIT-MTSVKIT-MT2024-08-20
D769PDAIAL0Park Dental Research Corp.PDA-IALPDA-IAL2023-02-20
D769CMALIGN0Clear MovesCM-ALIGN2026-04-15
D769CMRETAIN0Clear MovesCM-RETAIN2026-04-15
D769WLALIGN0White LabelWL-ALIGN2026-04-15
D769WLRETAIN0White LabelWL-RETAIN2026-04-15
D769ORCALIGN0Orchestrate 3DORC-ALIGN2026-04-14
D769ORCRETAIN0Orchestrate 3DORC-RETAIN2026-04-14
D769PDAALIGN0Park Dental PDA-ALIGN2026-04-14
D769PDARETAIN0Park Dental PDA-RETAIN2026-04-14
D769CMIAL0Clear MovesCM-IAL2025-12-16
D769O3D0Orchestrate 3DO3D2025-07-17
D769P45450IMTEC IM-P4545P45452025-05-13
D769XP45450IMTEC IM-XP4545XP45452025-05-13
D769P45410IMTEC IM-P4541P45412025-05-12
D769P45430IMTEC IM-P4543P45432025-05-12
D769XP45410IMTEC IM-XP4541XP-45412025-05-12
D769XP45430IMTEC IM-XP4543XP45432025-05-12
D7693510MOB0IMTEC 3510-MOB3510-MOB2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
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07392532002069Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
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07392532002397Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14