Salvin Dental Specialties MEIS-BE001-230-070

GUDID 00841336120877

Narrow Extraction Screw For Benex Pro Atraumatic Extraction Kit - 1.3mm x 16mm

SALVIN DENTAL SPECIALTIES, LLC

Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 00841336120877
• NIH Device Record Key: e58e595d-0378-47fe-ae9e-1d6cdfb83c90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salvin Dental Specialties
• Version Model Number: MEIS-BE001-230-070
• Catalog Number: MEIS-BE001-230-070
• Company DUNS: 113344790
• Company Name: SALVIN DENTAL SPECIALTIES, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00841336120877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073342

FDA Product Code

• DZL: SCREW, FIXATION, INTRAOSSEOUS

Sterilization

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

[00841336120877]

Moist Heat or Steam Sterilization

[00841336120877]

Moist Heat or Steam Sterilization

[00841336120877]

Moist Heat or Steam Sterilization

[00841336120877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-19
• Device Publish Date: 2024-12-11

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• 00841336139091: 10mm Cutting Length Oscillating Blade
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• 00841336137363: Silicon Guards for Molt Mouth Gag-Child
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• 00841336126312: Sinus Comp Kit Aqua Tip 4.2
• 00841336126305: Sinus Comp Kit Aqua Tip 4.0
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• 00841336126282: Sinus Comp Kit Aqua Tip 3.5
• 00841336126275: Sinus Comp Kit Aqua Tip 3.3
• 00841336126268: Sinus Comp Kit Aqua Tip 3.0
• 00841336126251: Sinus Comp Kit Aqua Tip 2.8
• 00841336126244: Adapter for the Sinus Comp Kit
• 00841336126237: Aqua System for the Sinus Comp Kit
• 00841336126213: Lateral Reamer 6.5x3mm
• 00841336126206: Lateral Reamer 6.5x2mm
• 00841336126190: Sinus 8 mm Stopper
• 00841336126183: Sinus 7 mm Stopper
• 00841336126176: Sinus 6 mm Stopper
• 00841336126169: Sinus 5 mm Stopper
• 00841336126152: Sinus 4 mm Stopper
• 00841336126145: Sinus 3 mm Stopper
• 00841336126138: Sinus 2 mm Stopper
• 00841336126121: Sinus 1 mm Stopper
• 00841336126008: 4.2 Crest Reamer
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• 00841336125988: 3.3 Crest Reamer
• 00841336125971: 2.8 Crest Reamer
• 00841336125841: Meisinger 13mm Diameter Diamond Saw Disc
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• 00841336125827: DIAMOND DISC, 7.0MM DIAMOND COATED OSTEOTOMY SAW, EXTRA FINE GRIT, HP
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