FDA.reportPublic FDA data

Park Dental Research Corp.

Primary DI
D769NRP10
Brand
Park Dental Research Corp.
Company
PARK DENTAL RESEARCH CORP
Model
D2-II
Catalog number
NRP-1
Device description
NRpiezo + LED Narrow Ridge Piezo Surgical Unit w/LED
Published
2017-06-21
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
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111290000PIEZO BONE SURGERYGuilin Woodpecker Medical Instrument Co., Ltd.2011-11-18DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D769NRP10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutterA strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam 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
Serial number
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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07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
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J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021305030001Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
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J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
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J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030081Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030091Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030101Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
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J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030161Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22