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FDA 510(k)

S-53 INTRORAL DENTAL SYSTEM

K-Number: K962979 · 1996-09-25

ApplicantDel Medical Systems Corp.
Decision Date1996-09-25
Product CodeDZA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S-53 INTRORAL DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Del Medical Systems Corp.. It received FDA 510(k) clearance on 1996-09-25 under 510(k) number K962979. The device is classified under product code DZA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-53 INTRORAL DENTAL SYSTEM?

S-53 INTRORAL DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-25. The listed applicant is Del Medical Systems Corp.. The 510(k) number is K962979.

When did S-53 INTRORAL DENTAL SYSTEM receive FDA 510(k) clearance?

S-53 INTRORAL DENTAL SYSTEM received FDA 510(k) clearance on 1996-09-25, under 510(k) number K962979.

Who is the listed applicant for S-53 INTRORAL DENTAL SYSTEM?

The FDA 510(k) record lists Del Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-53 INTRORAL DENTAL SYSTEM?

The FDA product code for S-53 INTRORAL DENTAL SYSTEM is DZA.

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Other records listing Del Medical Systems Corp. 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.

K962684S-357 VIDEO IMAGING SYSTEMK960301ND VISION-220 ADAPTIVE IMAGE PROCESSESSORK962651S-52 ELECTRONIC VIDEO LAPAROSCOPEK962020S-41 & S-41S VIDEO IMAGING SYSTEMK962024S-57 VIDEO IMAGING SYSTEMK942924MSV-2000 VIDEO IMAGING SYSTEM

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Related Devices (Code: DZA)

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.

K984508SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MODW&H Dentalwerk Buermoos GmbHK954790PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSTulsa Dental Products, Ltd.K914724ADA SHANK EXTENSIONImplant Corp. of AmericaK905418GATES GLIDDEN DRILLSThe Hygenic Corp.K901097FILLOCK REAMERIvoclar North America, Inc.K896149ANEST-EZE DENTAL DRILL RA#2Signature One Products, 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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