Kerator

GUDID 08809488212200

KJMEDITECH.CO.,LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809488212200
• NIH Device Record Key: cde8d47c-1b52-4ff3-86c6-b739834bb0bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kerator
• Version Model Number: B507
• Company DUNS: 688476027
• Company Name: KJMEDITECH.CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809488212200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112787

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809488212200]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-08-26

On-Brand Devices [Kerator]

• 08809488213009: KMD619
• 08809488212996: CDPH2
• 08809488212989: T407
• 08809488212972: T406
• 08809488212965: T405
• 08809488212958: T404
• 08809488212941: T403
• 08809488212934: T402
• 08809488212927: T401
• 08809488212910: PA456
• 08809488212903: PA455
• 08809488212897: PA454
• 08809488212880: PA453
• 08809488212873: PA452
• 08809488212866: PA451
• 08809488212859: PA450
• 08809488212842: PA356
• 08809488212835: PA355
• 08809488212828: PA354
• 08809488212811: PA353
• 08809488212804: PA352
• 08809488212798: PA351
• 08809488212781: PA350
• 08809488212774: BC307
• 08809488212767: BC306
• 08809488212750: BC305
• 08809488212743: BC304
• 08809488212736: BC303
• 08809488212729: BC302
• 08809488212712: BC301
• 08809488212705: BC207
• 08809488212699: BC206
• 08809488212682: BC205
• 08809488212675: BC204
• 08809488212668: BC203
• 08809488212651: BC202
• 08809488212644: BC201
• 08809488212637: SRS506
• 08809488212620: SRS505
• 08809488212613: SRS504
• 08809488212606: SRS503
• 08809488212590: SRS502
• 08809488212583: SRS501
• 08809488212576: SRS500
• 08809488212569: SRS457
• 08809488212552: SRS456
• 08809488212545: SRS455
• 08809488212538: SRS454
• 08809488212521: SRS453
• 08809488212514: SRS452