| Primary Device ID | 08806343924292 |
| NIH Device Record Key | 577dd701-ec19-4bc0-8516-9a078c8057d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ever GUIDE KIT |
| Version Model Number | GFD5011 |
| Company DUNS | 689667152 |
| Company Name | Shinhung MST Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Phone | +82337301913 |
| jssong@shinhung.co.kr | |
| Phone | +82337301913 |
| jssong@shinhung.co.kr | |
| Phone | +82337301913 |
| jssong@shinhung.co.kr | |
| Phone | +82337301913 |
| jssong@shinhung.co.kr | |
| Phone | +82337301913 |
| jssong@shinhung.co.kr | |
| Phone | +82337301913 |
| jssong@shinhung.co.kr | |
| Phone | +82337301913 |
| jssong@shinhung.co.kr |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806343924292 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806343924292]
Moist Heat or Steam Sterilization
[08806343924292]
Moist Heat or Steam Sterilization
[08806343924292]
Moist Heat or Steam Sterilization
[08806343924292]
Moist Heat or Steam Sterilization
[08806343924292]
Moist Heat or Steam Sterilization
[08806343924292]
Moist Heat or Steam Sterilization
[08806343924292]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-24 |
| Device Publish Date | 2025-06-16 |
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| 08806343924551 | A dental implant surgical drill used to install dental implant fixtures, can drill only to a cer |
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| 08806343924537 | A dental implant surgical drill used to install dental implant fixtures, used to dig a hole to g |
| 08806343924520 | A dental implant surgical drill used to install dental implant fixtures, used to dig a hole to g |
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| 08806343924483 | A dental implant surgical drill used to install dental implant fixtures. It is used to correct d |
| 08806343924445 | A dental implant surgical drill used to install dental implant fixtures, can drill only to a cer |
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| 08806343924384 | This product is a dental implant screwdriver used to tighten or loosen fixtures, abutments, and |
| 08806343924377 | This product is a dental implant screwdriver used to tighten or loosen fixtures, abutments, and |
| 08806343924360 | This product is a dental implant screwdriver used to tighten or loosen fixtures, abutments, and |
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| 08806343924339 | A dental implant surgical drill used to install dental implant fixtures. It is used to expand th |
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| 08806343924315 | A dental implant surgical drill used to install dental implant fixtures. It is used to expand th |
| 08806343924308 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
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| 08806343924247 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
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| 08806343924223 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
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| 08806343924162 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
| 08806343924155 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
| 08806343924148 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
| 08806343924131 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
| 08806343924124 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
| 08806343924117 | A dental implant surgical drill used to install dental implant fixtures. Drilling can only be do |
| 08806343924100 | A dental implant surgical drill used to install dental implant fixtures. It is used to correct d |
| 08806343924094 | A dental implant surgical drill used to install dental implant fixtures. It is used to correct d |
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| 08806343924070 | A dental implant surgical drill used to install dental implant fixtures. It is used to correct d |
| 08806343924063 | This is a surgical drill for dental implants used to install dental implant fixtures. It is used |
| 08806343924056 | This is a dental implant surgical drill used to install dental implant fixtures, and is used to |
| 08806343924049 | It is used when removing the gums at the location where the fixture will be installed during den |
| 08806343924032 | This is a dental implant surgical instrument used when separating a broken prosthesis and screw |
| 08806343922915 | Dental Fixture is a kit consisting of dental implant surgical instruments required for surgery. |