FDA.report

Park Dental Research Corp.

Primary DI
D769BOS10
Brand
Park Dental Research Corp.
Company
PARK DENTAL RESEARCH CORP
Model
BOS-1
Device description
Block Out Shims 25 Pack
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D769BOS10PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods

Method

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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D769CMIAL0Clear MovesCM-IAL2025-12-16
D769O3D0Orchestrate 3DO3D2025-07-17
D76980281IMTEC 802880282025-05-14
D769IMP90230IMTEC IM-P9023P90232025-05-14
D769IMP9025DL0IMTEC IM-P9025DLP9025DL2025-05-14
D769IMP90450IMTEC IM-P9045P90452025-05-14
D769IMXP9025DL0IMTEC IM-XP9025DLXP9025DL2025-05-14
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800076409989Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076409996Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410008Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410015Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410022Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410039Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410046Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410053Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076414440AOT Digital AnalogTruabutment Korea Co.,LtdNDP2026-03-24
08800076414662Multi-Unit Burn Out CylinderTruabutment Korea Co.,LtdNDP2026-03-24
08800076414679Multi-Unit Burn Out CylinderTruabutment Korea Co.,LtdNDP2026-03-24
08800076418073Drill ExtensionTruabutment Korea Co.,LtdNDP2026-03-24
08800076423664URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423671URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423718URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423725URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24