Ace SDS 3.75MM Screw Dental Implant
FDA 510(k) K002075 · Ace Surgical Supply Co., Inc.
510(k) numberK002075
Submission
- Device name
- Ace SDS 3.75MM Screw Dental Implant
- Applicant
- Ace Surgical Supply Co., Inc.
Brockton, MA, US - Received
- July 10, 2000
- Decision date
- February 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
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| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
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More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K103790 | Ace Trimark Tricam Dental ImplantDZE · Traditional | 08/18/2011SE |
| K102981 | Ace Freedom Internal Hexagon Dental Implant SystemDZE · Special | 12/20/2010SE |
| K093518 | Ace Surgical Secure Locator 3.25 Implant SystemDZE · Special | 01/14/2010SE |
| K092594 | Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXDZE · Special | 09/16/2009SE |
| K073343 | Ace Surgical Secure-Mini Implant System, Model 09-270X-XXDZE · Traditional | 03/13/2008SE |
| K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XXDZE · Special | 02/14/2008SE |
| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…OAT · Traditional | 08/16/2006SE |
| K051381 | Ace Surgicalplaster Calcium Sulface HemihydrateLYC · Traditional | 07/15/2005SE |
| K041759 | Ace Connect Internal ConnectionDZE · Special | 07/22/2004SE |
| K021244 | Ace Ha Screw Dental Implant SystemDZE · Special | 05/03/2002SE |
Questions and answers
When was Ace SDS 3.75MM Screw Dental Implant cleared by the FDA?
Ace SDS 3.75MM Screw Dental Implant (K002075) received a 510(k) decision of Substantially Equivalent on February 2, 2001, 207 days after the submission was received.
What is the product code of K002075?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.