Identity
- Trade Name
- Connect Internal Screw Dental Implant FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- 1.5MM TWO PIECE PREPABLE ABUTMENT SCREW CONNECT 4MM SYS TI 6AL 4V ELI FDA UDI
- Model / Reference
- 19453501 FDA UDI
- Description
- 1.5MM TWO PIECE PREPABLE ABUTMENT SCREW CONNECT 4MM SYS TI 6AL 4V ELI FDA UDI
Identifiers
- Catalog Number
- 19453501 FDA UDI
- Primary DI / UDI-DI
- 00614950004041 FDA UDI
- 510(k) Number
- K041759 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 4 Millimeter FDA UDI
Category: Screw endosteal dental implant, one-piece
Connect Internal Screw Dental Implant by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, one-piece.
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Cleared under the same submission
K041759 also covers:
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
- Connect Internal Screw Dental Implant — ACE SURGICAL SUPPLY CO., INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI be805db7-101f-418f-aeb5-fb4283f1bafb 37 fields · synced Jun 8, 2026