FDA.report

Park Dental Research Corp.

Primary DI
D769DRVRT204L0
Brand
Park Dental Research Corp.
Company
PARK DENTAL RESEARCH CORP
Model
DRVRT-2.04L
Device description
3.0 Multi-Purpose Driver Long / 2.0 mm O-Ball Abutment Driver Long
Published
2016-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D769DRVRT204L0PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-800-243-7372info@pdrus.com

Regulatory Flags

DUNS number
011441508
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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D769JGUN10IMTEC IM-JGUN-1JGUN-12025-05-14
D76987010IMTEC IM-870187012025-05-13
D769P45420IMTEC IM-P4542P45422025-05-13
D769P45450IMTEC IM-P4545P45452025-05-13
D769P51430IMTEC IM-P5143P51432025-05-13
D769P51440IMTEC IM-P5144P51442025-05-13
D769P51450IMTEC IM-P5145P51452025-05-13
D769XP45420IMTEC IM-XP4542XP-45422025-05-13
D769XP45450IMTEC IM-XP4545XP45452025-05-13
D769XP51430IMTEC IM-XP5143XP51432025-05-13
D769LEW0010IMTEC IM-LEW-001LEW-0012025-05-12
D769LEW001A0IMTEC IM-LEW-001ALEW-001A2025-05-12
D769LEW0020IMTEC IM-LEW-002LEW-0022025-05-12

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06438311708782LMDentalLM-DentalDZN2026-05-25
06438311708799LMDentalLM-DentalDZN2026-05-25
06438311708805LMDentalLM-DentalDZN2026-05-25
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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00840479202600RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
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00840479201061COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
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