FDA.report

Intra-Lock

Primary DI
D742SDK0
Brand
Intra-Lock
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
SDK
Catalog number
SDK
Device description
STARTER DRILLS KIT (EMPTY)
Published
2019-07-11
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
OFYDental Implant Surgical Tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D742SDK0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
131500998
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
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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D742OP3011OPOP3011OP30112017-02-13
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D742S34130BlossomS3413S34132017-02-07
D742S34150BlossomS3415S34152017-02-07
D742S37080BlossomS3708S37082017-02-07
D742S37100BlossomS3710S37102017-02-07
D742S37110BlossomS3711S37112017-02-07
D742S37130BlossomS3713S37132017-02-07
D742S37150BlossomS3715S37152017-02-07
D742SCT40100BlossomSCT4010SCT40102017-02-07
D742SCT40110BlossomSCT4011SCT40112017-02-07
D742SCT40130BlossomSCT4013SCT40132017-02-07
D742SCT40150BlossomSCT4015SCT40152017-02-07

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07290116770017Guided Surgery Accessories TRAY - RS ImplantsADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
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07290116772783OsseoSave Master NC Kit TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-15
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07290116775494SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776507SS SafeDepth TrayADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776514 SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
07290116776521SS SafeDepth Kit ADIN DENTAL IMPLANT SYSTEMS LTDOFY2025-12-01
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04260516874885SIC invent Dental Implant SystemsSIC invent AGOFY2024-10-18
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