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FDA 510(k)

ACE ALVEOLAR DISTRACTOR

K-Number: K981526 · 1998-11-06

ApplicantAce Surgical Supply Co., Inc.
Decision Date1998-11-06
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACE ALVEOLAR DISTRACTOR 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 1998-11-06 under 510(k) number K981526. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE ALVEOLAR DISTRACTOR?

ACE ALVEOLAR DISTRACTOR is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Ace Surgical Supply Co., Inc.. The 510(k) number is K981526.

When did ACE ALVEOLAR DISTRACTOR receive FDA 510(k) clearance?

ACE ALVEOLAR DISTRACTOR received FDA 510(k) clearance on 1998-11-06, under 510(k) number K981526.

Who is the listed applicant for ACE ALVEOLAR DISTRACTOR?

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 ALVEOLAR DISTRACTOR?

The FDA product code for ACE ALVEOLAR DISTRACTOR is JEY.

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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: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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