FDA.report

Patterson

Primary DI
D6620708764580
Brand
Patterson
Company
PATTERSON DENTAL SUPPLY, INC.
Model
087-6458
Catalog number
70876458
Device description
DRILL, DENTAL, INTRAORAL
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6620708764581PrimaryHIBCC0
D6620708764580Unit of UseHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
171843584
Device count
6
DM exempt
false
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
D6620714708480Patterson®25-PAT714708482025-02-06
D6620714708550Patterson®15-PAT714708552025-02-06
D6620714708630Patterson®65-PAT714708632025-02-06
D6620714708710Patterson®204-PAT714708712025-02-06
D6620714708890Patterson®57-PAT714708892025-02-06
D6620714969590Patterson®22-PAT714969592025-02-06
D6620708506692Patterson®70850669708506692016-09-23
D6620708506932Patterson®70850693708506932016-09-23
D6620708507502Patterson®70850750708507502016-09-23
D6620708508002Patterson®70850800708508002016-09-23
D6620703523022Patterson®70352302703523022016-09-23
D6620704114962Patterson®70411496704114962016-09-23
D6620704115042Patterson®70411504704115042016-09-23
D6620704115122Patterson®70411512704115122016-09-23
D6620704115202Patterson®70411520704115202016-09-23
D6620704115382Patterson®70411538704115382016-09-23
D6620704115462Patterson®70411546704115462016-09-23
D6620704115532Patterson®70411553704115532016-09-23
D6620704115790Patterson®70411579704115792016-09-23
D6620704115870Patterson®70411587704115872016-09-23

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