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FDA 510(k)

ACE SDS 3.75MM SCREW DENTAL IMPLANT

K-Number: K002075 · 2001-02-02

ApplicantAce Surgical Supply Co., Inc.
Decision Date2001-02-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACE SDS 3.75MM SCREW DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Ace Surgical Supply Co., Inc.. It received FDA 510(k) clearance on 2001-02-02 under 510(k) number K002075. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE SDS 3.75MM SCREW DENTAL IMPLANT?

ACE SDS 3.75MM SCREW DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2001-02-02. The listed applicant is Ace Surgical Supply Co., Inc.. The 510(k) number is K002075.

When did ACE SDS 3.75MM SCREW DENTAL IMPLANT receive FDA 510(k) clearance?

ACE SDS 3.75MM SCREW DENTAL IMPLANT received FDA 510(k) clearance on 2001-02-02, under 510(k) number K002075.

Who is the listed applicant for ACE SDS 3.75MM SCREW DENTAL IMPLANT?

The FDA 510(k) record lists Ace Surgical Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE SDS 3.75MM SCREW DENTAL IMPLANT?

The FDA product code for ACE SDS 3.75MM SCREW DENTAL IMPLANT is DZE.

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Other records listing Ace Surgical Supply Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093518ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEMK092594ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OXK073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XXK080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XXK061397ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, MK051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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