FDA.report

Drill Stop

Primary DI
D765DS56060
Brand
Drill Stop
Company
OCO BIOMEDICAL INC
Model
Drill Stop For 0560T, 6mm
Catalog number
DS 5.6-06
Device description
Drill Stop For 0560T Drill, 6mm
Published
2024-03-11
Public version status
New
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

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D765DS56060PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical instrument/implant depth limiterA device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
094146123
Device count
1
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
true
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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D785OTPINK404 PACK OT EQUATOR PINK INSERTSOT PINK 4OT PINK 42026-02-04
D785OTPU202 PACK OT EQUATOR IMPRESSION COPINGOT PU 2OT PU 22026-02-04
D785OTYELLOW404 PACK OT EQUATOR YELLOW INSERTOT YELLOW 4OT YELLOW 42026-02-04
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D7850330T0Osteotomy Former3.3mm Osteotomy Former0330TN2024-12-03
D7853610ENGAGE0Two Stage Bone Level Dental ImplantEngage3610 ENGAGE2024-12-03
D7853610ENGPLS0Two Stage Bone Level ImplantEngage Plus3610 Engage Plus2024-12-03
D7853612ENGAGE0Two Stage Bone Level Dental ImplantEngage3612 ENGAGE2024-12-03
D7853612ENGPLS0Two Stage Bone Level ImplantEngage Plus3612 Engage plus2024-12-03
D7853614ENGAGE0Two Stage Bone Level Dental ImplantEngage3614 ENGAGE2024-12-03
D7853614ENGPLS0Two Stage Bone Level ImplantEngage Plus3614 Engage Plus2024-12-03
D7853616ENGAGE0Two Stage Bone Level Dental Implant Engage3616 ENGAGE2024-12-03
D7853616ENGPLS0Two Stage Bone Level ImplantEngage Plus3616 Engage Plus2024-12-03
D785SURGICALGUIDE0SURGICAL GUIDE3D PRINTED SURGICAL GUIDESURGICAL GUIDE2024-12-03
D7856006ENGPLS0Two Stage Bone Level ImplantEngage Plus6006 Engage Plus2024-09-27
D785293325CBTI0SDI Crown and Bridge Abutments (Ti)2.9/3/3.25MM SDI C&B ABUTMENT2.9/3/3.25 CB (Ti)2024-06-28
D785SDI2225CBTI0SDI Crown and Bridge Abutments (Ti)2.2/2.5MM SDI C&B ABUTMENTSDI 2.2/2.5 CB (Ti)2024-06-28
D785002CAPWOBN0HOUSING CAP WITH O-RING002 CAP W/O-RING (002BN900)002 CAP W/O-RING (002BN900)2024-06-26

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